cfr_sections
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46 rows where part_number = 814 sorted by section_id
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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
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| 21:21:8.0.1.1.11.1.1.1 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | A | Subpart A—General | § 814.1 Scope. | FDA | [51 FR 26364, July 22, 1986, as amended at 79 FR 1740, Jan. 10, 2014] | (a) This section implements sections 515 and 515A of the act by providing procedures for the premarket approval of medical devices intended for human use. (b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted. (c) This part applies to any class III medical device, unless exempt under section 520(g) of the act, that: (1) Was not on the market (introduced or delivered for introduction into commerce for commercial distribution) before May 28, 1976, and is not substantially equivalent to a device on the market before May 28, 1976, or to a device first marketed on, or after that date, which has been classified into class I or class II; or (2) Is required to have an approved premarket approval application (PMA) or a declared completed product development protocol under a regulation issued under section 515(b) of the act; or (3) Was regulated by FDA as a new drug or antibiotic drug before May 28, 1976, and therefore is governed by section 520(1) of the act. (d) This part amends the conditions to approval for any PMA approved before the effective date of this part. Any condition to approval for an approved PMA that is inconsistent with this part is revoked. Any condition to approval for an approved PMA that is consistent with this part remains in effect. | |||
| 21:21:8.0.1.1.11.1.1.2 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | A | Subpart A—General | § 814.2 Purpose. | FDA | The purpose of this part is to establish an efficient and thorough device review process— (a) To facilitate the approval of PMA's for devices that have been shown to be safe and effective and that otherwise meet the statutory criteria for approval; and (b) To ensure the disapproval of PMA's for devices that have not been shown to be safe and effective or that do not otherwise meet the statutory criteria for approval. This part shall be construed in light of these objectives. | ||||
| 21:21:8.0.1.1.11.1.1.3 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | A | Subpart A—General | § 814.3 Definitions. | FDA | [51 FR 26364, July 22, 1986, as amended at 61 FR 15190, Apr. 5, 1996; 61 FR 33244, June 26, 1996; 73 FR 49610, Aug. 22, 2008; 78 FR 58821, Sept. 24, 2013; 79 FR 1740, Jan. 10, 2014; 82 FR 26349, June 7, 2017] | For the purposes of this part: (a) Act means the Federal Food, Drug, and Cosmetic Act (sections 201-902, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321-392)). (b) FDA means the Food and Drug Administration. (c) IDE means an approved or considered approved investigational device exemption under section 520(g) of the act and parts 812 and 813. (d) Master file means a reference source that a person submits to FDA. A master file may contain detailed information on a specific manufacturing facility, process, methodology, or component used in the manufacture, processing, or packaging of a medical device. (e) PMA means any premarket approval application for a class III medical device, including all information submitted with or incorporated by reference therein. “PMA” includes a new drug application for a device under section 520(1) of the act. (f) PMA amendment means information an applicant submits to FDA to modify a pending PMA or a pending PMA supplement. (g) PMA supplement means a supplemental application to an approved PMA for approval of a change or modification in a class III medical device, including all information submitted with or incorporated by reference therein. (h) Person includes any individual, partnership, corporation, association, scientific or academic establishment, Government agency, or organizational unit thereof, or any other legal entity. (i) Statement of material fact means a representation that tends to show that the safety or effectiveness of a device is more probable than it would be in the absence of such a representation. A false affirmation or silence or an omission that would lead a reasonable person to draw a particular conclusion as to the safety or effectiveness of a device also may be a false statement of material fact, even if the statement was not intended by the person making it to be misleading or to have any probative effect. (j) 30-day PMA supplement means a supplemental application to an approved PMA in accordance with § 814.39(e). (k) Reas… | |||
| 21:21:8.0.1.1.11.1.1.4 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | A | Subpart A—General | § 814.9 Confidentiality of data and information in a premarket approval application (PMA) file. | FDA | [51 FR 26364, July 22, 1986, as amended at 61 FR 51531, Oct. 2, 1996; 88 FR 45067, July 14, 2023] | (a) A “PMA file” includes all data and information submitted with or incorporated by reference in the PMA, any IDE incorporated into the PMA, any PMA supplement, any report under § 814.82, any master file, or any other related submission. Any record in the PMA file will be available for public disclosure in accordance with the provisions of this section and part 20. The confidentiality of information in a color additive petition submitted as part of a PMA is governed by § 71.15. (b) The existence of a PMA file may not be disclosed by FDA before an approval order is issued to the applicant unless it previously has been publicly disclosed or acknowledged. (c) If the existence of a PMA file has not been publicly disclosed or acknowledged, data or information in the PMA file are not available for public disclosure. (d)(1) If the existence of a PMA file has been publicly disclosed or acknowledged before an order approving, or an order denying approval of the PMA is issued, data or information contained in the file are not available for public disclosure before such order issues. FDA may, however, disclose a summary of portions of the safety and effectiveness data before an approval order or an order denying approval of the PMA issues if disclosure is relevant to public consideration of a specific pending issue. (2) Notwithstanding paragraph (d)(1) of this section, FDA will make available to the public upon request the information in the IDE that was required to be filed in Docket Number 95S-0158 in the Dockets Management Staff (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, for investigations involving an exception from informed consent under § 50.24 of this chapter. Persons wishing to request this information shall submit a request under the Freedom of Information Act. (e) Upon issuance of an order approving, or an order denying approval of any PMA, FDA will make available to the public the fact of the existence of the PMA and a detailed summary of information submitte… | |||
| 21:21:8.0.1.1.11.1.1.5 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | A | Subpart A—General | § 814.15 Research conducted outside the United States. | FDA | [51 FR 26364, July 22, 1986; 51 FR 40415, Nov. 7, 1986, as amended at 51 FR 43344, Dec. 2, 1986; 83 FR 7387, Feb. 21, 2018] | (a) Data to support PMA. If data from clinical investigations conducted outside the United States are submitted to support a PMA, the applicant shall comply with the provisions in § 812.28 of this chapter, as applicable. (b) As sole basis for marketing approval. A PMA based solely on foreign clinical data and otherwise meeting the criteria for approval under this part may be approved if: (1) The foreign data are applicable to the U.S. population and U.S. medical practice; (2) The studies have been performed by clinical investigators of recognized competence; and (3) The data may be considered valid without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA can validate the data through an on-site inspection or other appropriate means. (c) Consultation between FDA and applicants. Applicants are encouraged to meet with FDA officials in a “presubmission” meeting when approval based solely on foreign data will be sought. | |||
| 21:21:8.0.1.1.11.1.1.6 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | A | Subpart A—General | § 814.17 Service of orders. | FDA | Orders issued under this part will be served in person by a designated officer or employee of FDA on, or by registered mail to, the applicant or the designated agent at the applicant's or designated agent's last known address in FDA's records. | ||||
| 21:21:8.0.1.1.11.1.1.7 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | A | Subpart A—General | § 814.19 Product development protocol (PDP). | FDA | A class III device for which a product development protocol has been declared completed by FDA under this chapter will be considered to have an approved PMA. | ||||
| 21:21:8.0.1.1.11.2.1.1 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | B | Subpart B—Premarket Approval Application (PMA) | § 814.20 Application. | FDA | [51 FR 26364, July 22, 1986; 51 FR 40415, Nov. 7, 1986, as amended at 51 FR 43344, Dec. 2, 1986; 55 FR 11169, Mar. 27, 1990; 62 FR 40600, July 29, 1997; 63 FR 5253, Feb. 2, 1998; 65 FR 17137, Mar. 31, 2000; 65 FR 56480, Sept. 19, 2000; 67 FR 9587, Mar. 4, 2002; 71 FR 42048, July 25, 2006; 72 FR 17399, Apr. 9, 2007; 73 FR 34859, June 19, 2008; 74 FR 14478, Mar. 31, 2009; 75 FR 20915, Apr. 22, 2010; 78 FR 18233, Mar. 26, 2013; 79 FR 1740, Jan. 10, 2014; 80 FR 18094, Apr. 3, 2015; 83 FR 7387, Feb. 21, 2018; 84 FR 68339, Dec. 16, 2019] | (a) The applicant or an authorized representative shall sign the PMA. If the applicant does not reside or have a place of business within the United States, the PMA shall be countersigned by an authorized representative residing or maintaining a place of business in the United States and shall identify the representative's name and address. (b) Unless the applicant justifies an omission in accordance with paragraph (d) of this section, a PMA shall include in electronic format: (1) The name and address of the applicant. (2) A table of contents that specifies the volume and page number for each item referred to in the table. A PMA shall include separate sections on nonclinical laboratory studies and on clinical investigations involving human subjects. A PMA shall be submitted as a single version. The applicant shall include information that it believes to be trade secret or confidential commercial or financial information in the PMA and identify the information that it believes to be trade secret or confidential commercial or financial information. (3) A summary in sufficient detail that the reader may gain a general understanding of the data and information in the application. The summary shall contain the following information: (i) Indications for use. A general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended. (ii) Device description. An explanation of how the device functions, the basic scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device. A brief description of the manufacturing process should be included if it will significantly enhance the reader's understanding of the device. The generic name of the device as well as any proprietary name or trade name should be included. (iii) Alternative practices and procedures. A description of existing alternative practices or procedures for diagno… | |||
| 21:21:8.0.1.1.11.2.1.2 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | B | Subpart B—Premarket Approval Application (PMA) | § 814.37 PMA amendments and resubmitted PMAs. | FDA | [51 FR 26364, July 22, 1986, as amended at 79 FR 1740, Jan. 10, 2014] | (a) An applicant may amend a pending PMA or PMA supplement to revise existing information or provide additional information. (b)(1) FDA may request the applicant to amend a PMA or PMA supplement with any information regarding the device that is necessary for FDA or the appropriate advisory committee to complete the review of the PMA or PMA supplement. (2) FDA may request the applicant to amend a PMA or PMA supplement with information concerning pediatric uses as required under §§ 814.20(b)(13) and 814.39(c)(2). (c) A PMA amendment submitted to FDA shall include the PMA or PMA supplement number assigned to the original submission and, if submitted on the applicant's own initiative, the reason for submitting the amendment. FDA may extend the time required for its review of the PMA, or PMA supplement, as follows: (1) If the applicant on its own initiative or at FDA's request submits a major PMA amendment (e.g., an amendment that contains significant new data from a previously unreported study, significant updated data from a previously reported study, detailed new analyses of previously submitted data, or significant required information previously omitted), the review period may be extended up to 180 days. (2) If an applicant declines to submit a major amendment requested by FDA, the review period may be extended for the number of days that elapse between the date of such request and the date that FDA receives the written response declining to submit the requested amendment. (d) An applicant may on its own initiative withdraw a PMA or PMA supplement. If FDA requests an applicant to submit a PMA amendment and a written response to FDA's request is not received within 180 days of the date of the request, FDA will consider the pending PMA or PMA supplement to be withdrawn voluntarily by the applicant. (e) An applicant may resubmit a PMA or PMA supplement after withdrawing it or after it is considered withdrawn under paragraph (d) of this section, or after FDA has refused to accept it for filing, or has denied a… | |||
| 21:21:8.0.1.1.11.2.1.3 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | B | Subpart B—Premarket Approval Application (PMA) | § 814.39 PMA supplements. | FDA | [51 FR 26364, July 22, 1986, as amended at 51 FR 43344, Dec. 2, 1986; 63 FR 54044, Oct. 8, 1998; 67 FR 9587, Mar. 4, 2002; 69 FR 11313, Mar. 10, 2004; 72 FR 73602, Dec. 28, 2007; 73 FR 49610, Aug. 22, 2008; 79 FR 1740, Jan. 10, 2014; 84 FR 68340, Dec. 16, 2019; 89 FR 18793, Mar. 15, 2024] | (a) After FDA's approval of a PMA, an applicant shall submit a PMA supplement for review and approval by FDA before making a change affecting the safety or effectiveness of the device for which the applicant has an approved PMA, unless the change is of a type for which FDA, under paragraph (e) of this section, has advised that an alternate submission is permitted or is of a type which, under section 515(d)(6)(A) of the act and paragraph (f) of this section, does not require a PMA supplement under this paragraph. While the burden for determining whether a supplement is required is primarily on the PMA holder, changes for which an applicant shall submit a PMA supplement include, but are not limited to, the following types of changes if they affect the safety or effectiveness of the device: (1) New indications for use of the device. (2) Labeling changes. (3) The use of a different facility or establishment to manufacture, process, or package the device. (4) Changes in sterilization procedures. (5) Changes in packaging. (6) Changes in the performance or design specifications, circuits, components, ingredients, principle of operation, or physical layout of the device. (7) Extension of the expiration date of the device based on data obtained under a new or revised stability or sterility testing protocol that has not been approved by FDA. If the protocol has been approved, the change shall be reported to FDA under paragraph (b) of this section. (b) An applicant may make a change in a device after FDA's approval of a PMA for the device without submitting a PMA supplement if the change does not affect the device's safety or effectiveness and the change is reported to FDA in post approval periodic reports required as a condition to approval of the device, e.g., an editorial change in labeling which does not affect the safety or effectiveness of the device, or if the change is consistent with a predetermined change control plan (PCCP) approved under section 515C of the act. (c)(1) All procedures and actions that … | |||
| 21:21:8.0.1.1.11.3.1.1 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | C | Subpart C—FDA Action on a PMA | § 814.40 Time frames for reviewing a PMA. | FDA | [51 FR 26364, July 22, 1986, as amended at 87 FR 2045, Jan. 13, 2022] | Within 180 days after receipt of an application that is accepted for filing and to which the applicant does not submit a major amendment, FDA will review the PMA and, after receiving the report and recommendation of the appropriate FDA advisory committee, send the applicant an approval order under § 814.44(d), an approvable letter under § 814.44(e), a not approvable letter under § 814.44(f), or an order denying approval under § 814.45. The approvable letter and the not approvable letter will provide an opportunity for the applicant to amend or withdraw the application, or to consider the letter to be a denial of approval of the PMA under § 814.45 and to request administrative review under section 515 (d)(4) and (g) of the act. | |||
| 21:21:8.0.1.1.11.3.1.2 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | C | Subpart C—FDA Action on a PMA | § 814.42 Filing a PMA. | FDA | [51 FR 26364, July 22, 1986, as amended at 63 FR 5254, Feb. 2, 1998; 73 FR 49942, Aug. 25, 2008; 85 FR 18442, Apr. 2, 2020] | (a) The filing of an application means that FDA has made a threshold determination that the application is sufficiently complete to permit a substantive review. Within 45 days after a PMA is received by FDA, the agency will notify the applicant whether the application has been filed. (b) If FDA does not find that any of the reasons in paragraph (e) of this section for refusing to file the PMA applies, the agency will file the PMA and will notify the applicant in writing of the filing. The notice will include the PMA reference number and the date FDA filed the PMA. The date of filing is the date that a PMA accepted for filing was received by the agency. The 180-day period for review of a PMA starts on the date of filing. (c) If FDA refuses to file a PMA, the agency will notify the applicant of the reasons for the refusal. This notice will identify the deficiencies in the application that prevent filing and will include the PMA reference number. (d) If FDA refuses to file the PMA, the applicant may: (1) Resubmit the PMA with additional information necessary to comply with the requirements of section 515(c)(1) (A)-(G) of the act and § 814.20. A resubmitted PMA shall include the PMA reference number of the original submission. If the resubmitted PMA is accepted for filing, the date of filing is the date FDA receives the resubmission; (2) Request in writing within 10 working days of the date of receipt of the notice refusing to file the PMA, an informal conference with the Director of the associated Office of Health Technology to review FDA's decision not to file the PMA. FDA will hold the informal conference within 10 working days of its receipt of the request and will render its decision on filing within 5 working days after the informal conference. If, after the informal conference, FDA accepts the PMA for filing, the date of filing will be the date of the decision to accept the PMA for filing. If FDA does not reverse its decision not to file the PMA, the applicant may request reconsideration of the decision f… | |||
| 21:21:8.0.1.1.11.3.1.3 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | C | Subpart C—FDA Action on a PMA | § 814.44 Procedures for review of a PMA. | FDA | [51 FR 26364, July 22, 1986, as amended at 57 FR 58403, Dec. 10, 1992; 63 FR 4572, Jan. 30, 1998; 79 FR 1740, Jan. 10, 2014; 87 FR 2045, Jan. 13, 2022] | (a) FDA will begin substantive review of a PMA after the PMA is accepted for filing under § 814.42. FDA may refer the PMA to a panel on its own initiative, and will do so upon request of an applicant, unless FDA determines that the application substantially duplicates information previously reviewed by a panel. If FDA refers an application to a panel, FDA will forward the PMA, or relevant portions thereof, to each member of the appropriate FDA panel for review. During the review process, FDA may communicate with the applicant as set forth under § 814.37(b), or with a panel to respond to questions that may be posed by panel members or to provide additional information to the panel. FDA will maintain a record of all communications with the applicant and with the panel. (b) The advisory committee shall submit a report to FDA which includes the committee's recommendation and the basis for such recommendation on the PMA. Before submission of this report, the committee shall hold a public meeting to review the PMA in accordance with part 14. This meeting may be held by a telephone conference under § 14.22(g). The advisory committee report and recommendation may be in the form of a meeting transcript signed by the chairperson of the committee. (c) FDA will complete its review of the PMA and the advisory committee report and recommendation and, within the later of 180 days from the date of filing of the PMA under § 814.42 or the number of days after the date of filing as determined under § 814.37(c), issue an approval order under paragraph (d) of this section, an approvable letter under paragraph (e) of this section, a not approvable letter under paragraph (f) of this section, or an order denying approval of the application under § 814.45(a). (d)(1) FDA will issue to the applicant an order approving a PMA if none of the reasons in § 814.45 for denying approval of the application applies. FDA will approve an application on the basis of draft final labeling if the only deficiencies in the application concern editorial o… | |||
| 21:21:8.0.1.1.11.3.1.4 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | C | Subpart C—FDA Action on a PMA | § 814.45 Denial of approval of a PMA. | FDA | [51 FR 26364, July 22, 1986, as amended at 63 FR 4572, Jan. 30, 1998; 73 FR 34859, June 19, 2008; 76 FR 31470, June 1, 2011; 79 FR 68115, Nov. 14, 2014; 83 FR 7387, Feb. 21, 2018; 87 FR 2045, Jan. 13, 2022] | (a) FDA may issue an order denying approval of a PMA if the applicant fails to follow the requirements of this part or if, upon the basis of the information submitted in the PMA or any other information before the agency, FDA determines that any of the grounds for denying approval of a PMA specified in section 515(d)(2) (A)-(E) of the act applies. In addition, FDA may deny approval of a PMA for any of the following reasons: (1) The PMA contains a false statement of material fact; (2) The device's proposed labeling does not comply with the requirements in part 801 or part 809; (3) The applicant does not permit an authorized FDA employee an opportunity to inspect at a reasonable time and in a reasonable manner the facilities, controls, and to have access to and to copy and verify all records pertinent to the application; (4) A nonclinical laboratory study that is described in the PMA and that is essential to show that the device is safe for use under the conditions prescribed, recommended, or suggested in its proposed labeling, was not conducted in compliance with the good laboratory practice regulations in part 58 and no reason for the noncompliance is provided or, if it is, the differences between the practices used in conducting the study and the good laboratory practice regulations do not support the validity of the study; or (5) Any clinical investigation involving human subjects described in the PMA, subject to the institutional review board regulations in part 56 of this chapter or informed consent regulations in part 50 of this chapter or GCP referenced in § 814.15(a) and described in § 812.28(a) of this chapter, was not conducted in compliance with those regulations such that the rights or safety of human subjects were not adequately protected or the supporting data were determined to be otherwise unreliable. (b) FDA will issue any order denying approval of the PMA in accordance with § 814.17. The order will inform the applicant of the deficiencies in the PMA, including each applicable ground for den… | |||
| 21:21:8.0.1.1.11.3.1.5 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | C | Subpart C—FDA Action on a PMA | § 814.46 Withdrawal of approval of a PMA. | FDA | [51 FR 26364, July 22, 1986, as amended at 83 FR 7387, Feb. 21, 2018] | (a) FDA may issue an order withdrawing approval of a PMA if, from any information available to the agency, FDA determines that: (1) Any of the grounds under section 515(e)(1) (A)-(G) of the act applies. (2) Any postapproval requirement imposed by the PMA approval order or by regulation has not been met. (3) A nonclinical laboratory study that is described in the PMA and that is essential to show that the device is safe for use under the conditions prescribed, recommended, or suggested in its proposed labeling, was not conducted in compliance with the good laboratory practice regulations in part 58 and no reason for the noncompliance is provided or, if it is, the differences between the practices used in conducting the study and the good laboratory practice regulations do not support the validity of the study. (4) Any clinical investigation involving human subjects described in the PMA, subject to the institutional review board regulations in part 56 of this chapter or informed consent regulations in part 50 of this chapter or GCP referenced in § 814.15(a) and described in § 812.28(a) of this chapter, was not conducted in compliance with those regulations such that the rights or safety of human subjects were not adequately protected or the supporting data were determined to be otherwise unreliable. (b)(1) FDA may seek advice on scientific matters from any appropriate FDA advisory committee in deciding whether to withdraw approval of a PMA. (2) FDA may use information other than that submitted by the applicant in deciding whether to withdraw approval of a PMA. (c) Before issuing an order withdrawing approval of a PMA, FDA will issue the holder of the approved application a notice of opportunity for an informal hearing under part 16. (d) If the applicant does not request a hearing or if after the part 16 hearing is held the agency decides to proceed with the withdrawal, FDA will issue to the holder of the approved application an order withdrawing approval of the application. The order will be issued under § … | |||
| 21:21:8.0.1.1.11.3.1.6 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | C | Subpart C—FDA Action on a PMA | § 814.47 Temporary suspension of approval of a PMA. | FDA | [61 FR 15190, Apr. 5, 1996] | (a) Scope. (1) This section describes the procedures that FDA will follow in exercising its authority under section 515(e)(3) of the act (21 U.S.C. 360e(e)(3)). This authority applies to the original PMA, as well as any PMA supplement(s), for a medical device. (2) FDA will issue an order temporarily suspending approval of a PMA if FDA determines that there is a reasonable probability that continued distribution of the device would cause serious, adverse health consequences or death. (b) Regulatory hearing. (1) If FDA believes that there is a reasonable probability that the continued distribution of a device subject to an approved PMA would cause serious, adverse health consequences or death, FDA may initiate and conduct a regulatory hearing to determine whether to issue an order temporarily suspending approval of the PMA. (2) Any regulatory hearing to determine whether to issue an order temporarily suspending approval of a PMA shall be initiated and conducted by FDA pursuant to part 16 of this chapter. If FDA believes that immediate action to remove a dangerous device from the market is necessary to protect the public health, the agency may, in accordance with § 16.60(h) of this chapter, waive, suspend, or modify any part 16 procedure pursuant to § 10.19 of this chapter. (3) FDA shall deem the PMA holder's failure to request a hearing within the timeframe specified by FDA in the notice of opportunity for hearing to be a waiver. (c) Temporary suspension order. If the PMA holder does not request a regulatory hearing or if, after the hearing, and after consideration of the administrative record of the hearing, FDA determines that there is a reasonable probability that the continued distribution of a device under an approved PMA would cause serious, adverse health consequences or death, the agency shall, under the authority of section 515(e)(3) of the act, issue an order to the PMA holder temporarily suspending approval of the PMA. (d) Permanent withdrawal of approval of the PMA. If FDA issues an order … | |||
| 21:21:8.0.1.1.11.5.1.1 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | E | Subpart E—Postapproval Requirements | § 814.80 General. | FDA | A device may not be manufactured, packaged, stored, labeled, distributed, or advertised in a manner that is inconsistent with any conditions to approval specified in the PMA approval order for the device. | ||||
| 21:21:8.0.1.1.11.5.1.2 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | E | Subpart E—Postapproval Requirements | § 814.82 Postapproval requirements. | FDA | [51 FR 26364, July 22, 1986, as amended at 51 FR 43344, Dec. 2, 1986] | (a) FDA may impose postapproval requirements in a PMA approval order or by regulation at the time of approval of the PMA or by regulation subsequent to approval. Postapproval requirements may include as a condition to approval of the device: (1) Restriction of the sale, distribution, or use of the device as provided by section 515(d)(1)(B)(ii) or 520(e) of the act. (2) Continuing evaluation and periodic reporting on the safety, effectiveness, and reliability of the device for its intended use. FDA will state in the PMA approval order the reason or purpose for such requirement and the number of patients to be evaluated and the reports required to be submitted. (3) Prominent display in the labeling of a device and in the advertising of any restricted device of warnings, hazards, or precautions important for the device's safe and effective use, including patient information, e.g., information provided to the patient on alternative modes of therapy and on risks and benefits associated with the use of the device. (4) Inclusion of identification codes on the device or its labeling, or in the case of an implant, on cards given to patients if necessary to protect the public health. (5) Maintenance of records that will enable the applicant to submit to FDA information needed to trace patients if such information is necessary to protect the public health. Under section 519(a)(4) of the act, FDA will require that the identity of any patient be disclosed in records maintained under this paragraph only to the extent required for the medical welfare of the individual, to determine the safety or effectiveness of the device, or to verify a record, report, or information submitted to the agency. (6) Maintenance of records for specified periods of time and organization and indexing of records into identifiable files to enable FDA to determine whether there is reasonable assurance of the continued safety and effectiveness of the device. (7) Submission to FDA at intervals specified in the approval order of periodic reports co… | |||
| 21:21:8.0.1.1.11.5.1.3 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | E | Subpart E—Postapproval Requirements | § 814.84 Reports. | FDA | [51 FR 26364, July 22, 1986, as amended at 51 FR 43344, Dec. 2, 1986; 67 FR 9587, Mar. 4, 2002; 72 FR 73602, Dec. 28, 2007; 78 FR 58822, Sept. 24, 2013] | (a) The holder of an approved PMA shall comply with the requirements of part 803 and with any other requirements applicable to the device by other regulations in this subchapter or by order approving the device. (b) Unless FDA specifies otherwise, any periodic report shall: (1) Identify changes described in § 814.39(a) and changes required to be reported to FDA under § 814.39(b). (2) Contain a summary and bibliography of the following information not previously submitted as part of the PMA: (i) Unpublished reports of data from any clinical investigations or nonclinical laboratory studies involving the device or related devices and known to or that reasonably should be known to the applicant. (ii) Reports in the scientific literature concerning the device and known to or that reasonably should be known to the applicant. If, after reviewing the summary and bibliography, FDA concludes that the agency needs a copy of the unpublished or published reports, FDA will notify the applicant that copies of such reports shall be submitted. (3) Identify changes made pursuant to an exception or alternative granted under § 801.128 or § 809.11 of this chapter. (4) Identify each device identifier currently in use for the device, and each device identifier for the device that has been discontinued since the previous periodic report. It is not necessary to identify any device identifier discontinued prior to December 23, 2013. | |||
| 21:21:8.0.1.1.11.7.1.1 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | H | Subpart H—Humanitarian Use Devices | § 814.100 Purpose and scope. | FDA | [61 FR 33244, June 26, 1996, as amended at 63 FR 59220, Nov. 3, 1998; 73 FR 49942, Aug. 25, 2008; 79 FR 1740, Jan. 10, 2014; 82 FR 26349, June 7, 2017; 85 FR 18442, Apr. 2, 2020] | (a) This subpart H implements sections 515A and 520(m) of the act. (b) The purpose of section 520(m) is, to the extent consistent with the protection of the public health and safety and with ethical standards, to encourage the discovery and use of devices intended to benefit patients in the treatment or diagnosis of diseases or conditions that affect or are manifested in not more than 8,000 individuals in the United States per year. This subpart provides procedures for obtaining: (1) HUD designation of a medical device; and (2) Marketing approval for the HUD notwithstanding the absence of reasonable assurance of effectiveness that would otherwise be required under sections 514 and 515 of the act. (c) Section 515A of the act is intended to ensure the submission of readily available information concerning: (1) Any pediatric subpopulations (neonates, infants, children, adolescents) that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and (2) The number of affected pediatric patients. (d) Although a HUD may also have uses that differ from the humanitarian use, applicants seeking approval of any non-HUD use shall submit a PMA as required under § 814.20, or a premarket notification as required under part 807 of this chapter. (e) Obtaining marketing approval for a HUD involves two steps: (1) Obtaining designation of the device as a HUD from FDA's Office of Orphan Products Development, and (2) Submitting an HDE to the Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER), or the Center for Drug Evaluation and Research (CDER), as applicable. (f) A person granted an exemption under section 520(m) of the act shall submit periodic reports as described in § 814.126(b). (g) FDA may suspend or withdraw approval of an HDE after providing notice and an opportunity for an informal hearing. | |||
| 21:21:8.0.1.1.11.7.1.10 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | H | Subpart H—Humanitarian Use Devices | § 814.118 Denial of approval or withdrawal of approval of an HDE. | FDA | [61 FR 33244, June 26, 1996, as amended at 63 FR 59221, Nov. 3, 1998; 87 FR 2045, Jan. 13, 2022] | (a) FDA may deny approval or withdraw approval of an application if the applicant fails to meet the requirements of section 520(m) of the act or of this part, or of any condition of approval imposed by an IRB or by FDA, or any postapproval requirements imposed under § 814.126. In addition, FDA may deny approval or withdraw approval of an application if, upon the basis of the information submitted in the HDE or any other information before the agency, FDA determines that: (1) There is a lack of a showing of reasonable assurance that the device is safe under the conditions of use prescribed, recommended, or suggested in the labeling thereof; (2) The device is ineffective under the conditions of use prescribed, recommended, or suggested in the labeling thereof; (3) The applicant has not demonstrated that there is a reasonable basis from which to conclude that the probable benefit to health from the use of the device outweighs the risk of injury or illness, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment; (4) The application or a report submitted by or on behalf of the applicant contains an untrue statement of material fact, or omits material information; (5) The device's labeling does not comply with the requirements in part 801 or part 809 of this chapter; (6) A nonclinical laboratory study that is described in the HDE and that is essential to show that the device is safe for use under the conditions prescribed, recommended, or suggested in its proposed labeling, was not conducted in compliance with the good laboratory practice regulations in part 58 of this chapter and no reason for the noncompliance is provided or, if it is, the differences between the practices used in conducting the study and the good laboratory practice regulations do not support the validity of the study; (7) Any clinical investigation involving human subjects described in the HDE, subject to the institutional review board regulations in part 56 of this chapter or the… | |||
| 21:21:8.0.1.1.11.7.1.11 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | H | Subpart H—Humanitarian Use Devices | § 814.120 Temporary suspension of approval of an HDE. | FDA | [63 FR 59221, Nov. 3, 1998] | An HDE or HDE supplement may be temporarily suspended for the same reasons and in the same manner as prescribed for PMA's in § 814.47. | |||
| 21:21:8.0.1.1.11.7.1.12 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | H | Subpart H—Humanitarian Use Devices | § 814.122 Confidentiality of data and information. | FDA | (a) Requirement for disclosure. The “HDE file” includes all data and information submitted with or referenced in the HDE, any IDE incorporated into the HDE, any HDE amendment or supplement, any report submitted under § 814.126, any master file, or any other related submission. Any record in the HDE file will be available for public disclosure in accordance with the provisions of this section and part 20 of this chapter. (b) Extent of disclosure. Disclosure by FDA of the existence and contents of an HDE file shall be subject to the same rules that pertain to PMA's under § 814.9(b) through (h), as applicable. | ||||
| 21:21:8.0.1.1.11.7.1.13 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | H | Subpart H—Humanitarian Use Devices | § 814.124 Institutional Review Board requirements. | FDA | [61 FR 33244, June 26, 1996, as amended at 63 FR 59221, Nov. 3, 1998; 82 FR 26349, June 7, 2017] | (a) IRB approval. The HDE holder is responsible for ensuring that a HUD approved under this subpart is administered only in facilities having oversight by an Institutional Review Board (IRB) constituted and acting pursuant to part 56 of this chapter, including continuing review of use of the device. In addition, a HUD may be administered only if such use has been approved by an IRB. If, however, a physician in an emergency situation determines that approval from an IRB cannot be obtained in time to prevent serious harm or death to a patient, a HUD may be administered without prior approval by an IRB. In such an emergency situation, the physician shall, within 5 days after the use of the device, provide written notification to the chairman of the IRB of such use. Such written notification shall include the identification of the patient involved, the date on which the device was used, and the reason for the use. (b) Withdrawal of IRB approval. A holder of an approved HDE shall notify FDA of any withdrawal of approval for the use of a HUD by a reviewing IRB within 5 working days after being notified of the withdrawal of approval. | |||
| 21:21:8.0.1.1.11.7.1.14 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | H | Subpart H—Humanitarian Use Devices | § 814.126 Postapproval requirements and reports. | FDA | [61 FR 33244, June 26, 1996, as amended at 63 FR 59221, Nov. 3, 1998; 71 FR 16228, Mar. 31, 2006; 82 FR 26349, June 7, 2017] | (a) An HDE approved under this subpart H shall be subject to the postapproval requirements and reports set forth under subpart E of this part, as applicable, with the exception of § 814.82(a)(7). In addition, medical device reports submitted to FDA in compliance with the requirements of part 803 of this chapter shall also be submitted to the IRB of record. (b) In addition to the reports identified in paragraph (a) of this section, the holder of an approved HDE shall prepare and submit the following complete, accurate, and timely reports: (1) Periodic reports. An HDE applicant is required to submit reports in accordance with the approval order. Unless FDA specifies otherwise, any periodic report shall include: (i) An update of the information required under § 814.102(a) in a separately bound volume; (ii) An update of the information required under § 814.104(b)(2), (b)(3), and (b)(5); (iii) The number of devices that have been shipped or sold since initial marketing approval under this subpart H and, if the number shipped or sold exceeds 8,000, an explanation and estimate of the number of devices used per patient. If a single device is used on multiple patients, the applicant shall submit an estimate of the number of patients treated or diagnosed using the device together with an explanation of the basis for the estimate; (iv) Information describing the applicant's clinical experience with the device since the HDE was initially approved. This information shall include safety information that is known or reasonably should be known to the applicant, medical device reports made under part 803 of this chapter, any data generated from the postmarketing studies, and information (whether published or unpublished) that is known or reasonably expected to be known by the applicant that may affect an evaluation of the safety of the device or that may affect the statement of contraindications, warnings, precautions, and adverse reactions in the device's labeling; and (v) A summary of any changes made to the device in … | |||
| 21:21:8.0.1.1.11.7.1.2 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | H | Subpart H—Humanitarian Use Devices | § 814.102 Designation of HUD status. | FDA | [61 FR 33244, June 26, 1996, as amended at 82 FR 26349, June 7, 2017] | (a) Request for designation. Prior to submitting an HDE application, the applicant shall submit a request for HUD designation to FDA's Office of Orphan Products Development. The request shall contain the following: (1) A statement that the applicant requests HUD designation for a rare disease or condition or a valid subset of a disease or condition which shall be identified with specificity; (2) The name and address of the applicant, the name of the applicant's primary contact person and/or resident agent, including title, address, and telephone number; (3) A description of the rare disease or condition for which the device is to be used, the proposed indication or indications for use of the device, and the reasons why such therapy is needed. If the device is proposed for an indication that represents a subset of a common disease or condition, a demonstration that the subset is medically plausible should be included; (4) A description of the device and a discussion of the scientific rationale for the use of the device for the rare disease or condition; and (5) Documentation, with appended authoritative references, to demonstrate that the device is designed to treat or diagnose a disease or condition that affects or is manifested in not more than 8,000 people in the United States per year. If the device is for diagnostic purposes, the documentation must demonstrate that not more than 8,000 patients per year would be subjected to diagnosis by the device in the United States. Authoritative references include literature citations in specialized medical journals, textbooks, specialized medical society proceedings, or governmental statistics publications. When no such studies or literature citations exist, the applicant may be able to demonstrate the prevalence of the disease or condition in the United States by providing credible conclusions from appropriate research or surveys. (b) FDA action. Within 45 days of receipt of a request for HUD designation, FDA will take one of the following actions: (1) Approv… | |||
| 21:21:8.0.1.1.11.7.1.3 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | H | Subpart H—Humanitarian Use Devices | § 814.104 Original applications. | FDA | [61 FR 33244, June 26, 1996, as amended at 63 FR 59220, Nov. 3, 1998; 73 FR 49942, Aug. 25, 2008; 75 FR 20915, Apr. 22, 2010; 79 FR 1740, Jan. 10, 2014; 80 FR 18094, Apr. 3, 2015; 83 FR 7388, Feb. 21, 2018; 84 FR 68340, Dec. 16, 2019] | (a) United States applicant or representative. The applicant or an authorized representative shall sign the HDE. If the applicant does not reside or have a place of business within the United States, the HDE shall be countersigned by an authorized representative residing or maintaining a place of business in the United States and shall identify the representative's name and address. (b) Contents. Unless the applicant justifies an omission in accordance with paragraph (d) of this section, an HDE shall include: (1) A copy of or reference to the determination made by FDA's Office of Orphan Products Development (in accordance with § 814.102) that the device qualifies as a HUD; (2) An explanation of why the device would not be available unless an HDE were granted and a statement that no comparable device (other than another HUD approved under this subpart or a device under an approved IDE) is available to treat or diagnose the disease or condition. The application also shall contain a discussion of the risks and benefits of currently available devices or alternative forms of treatment in the United States; (3) An explanation of why the probable benefit to health from the use of the device outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. Such explanation shall include a description, explanation, or theory of the underlying disease process or condition, and known or postulated mechanism(s) of action of the device in relation to the disease process or condition; (4) All of the information required to be submitted under § 814.20(b), except that: (i) In lieu of the summaries, conclusions, and results from clinical investigations required under § 814.20(b)(3)(v)(B), (b)(3)(vi), and the introductory text of (b)(6)(ii), the applicant shall include the summaries, conclusions, and results of all clinical experience or investigations (whether adverse or supportive) reasonably obtainable by the appl… | |||
| 21:21:8.0.1.1.11.7.1.4 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | H | Subpart H—Humanitarian Use Devices | § 814.106 HDE amendments and resubmitted HDE's. | FDA | [63 FR 59220, Nov. 3, 1998] | An HDE or HDE supplement may be amended or resubmitted upon an applicant's own initiative, or at the request of FDA, for the same reasons and in the same manner as prescribed for PMA's in § 814.37, except that the timeframes set forth in § 814.37(c)(1) and (d) do not apply. If FDA requests an HDE applicant to submit an HDE amendment, and a written response to FDA's request is not received within 75 days of the date of the request, FDA will consider the pending HDE or HDE supplement to be withdrawn voluntarily by the applicant. Furthermore, if the HDE applicant, on its own initiative or at FDA's request, submits a major amendment as described in § 814.37(c)(1), the review period may be extended up to 75 days. | |||
| 21:21:8.0.1.1.11.7.1.5 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | H | Subpart H—Humanitarian Use Devices | § 814.108 Supplemental applications. | FDA | [63 FR 59220, Nov. 3, 1998] | After FDA approval of an original HDE, an applicant shall submit supplements in accordance with the requirements for PMA's under § 814.39, except that a request for a new indication for use of a HUD shall comply with requirements set forth in § 814.110. The timeframes for review of, and FDA action on, an HDE supplement are the same as those provided in § 814.114 for an HDE. | |||
| 21:21:8.0.1.1.11.7.1.6 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | H | Subpart H—Humanitarian Use Devices | § 814.110 New indications for use. | FDA | (a) An applicant seeking a new indication for use of a HUD approved under this subpart H shall obtain a new designation of HUD status in accordance with § 814.102 and shall submit an original HDE in accordance with § 814.104. (b) An application for a new indication for use made under § 814.104 may incorporate by reference any information or data previously submitted to the agency under an HDE. | ||||
| 21:21:8.0.1.1.11.7.1.7 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | H | Subpart H—Humanitarian Use Devices | § 814.112 Filing an HDE. | FDA | [61 FR 33244, June 26, 1996, as amended at 63 FR 5254, Feb. 2, 1998; 63 FR 59221, Nov. 3, 1998] | (a) The filing of an HDE means that FDA has made a threshold determination that the application is sufficiently complete to permit substantive review. Within 30 days from the date an HDE is received by FDA, the agency will notify the applicant whether the application has been filed. FDA may refuse to file an HDE if any of the following applies: (1) The application is incomplete because it does not on its face contain all the information required under § 814.104(b); (2) FDA determines that there is a comparable device available (other than another HUD approved under this subpart or a device under an approved IDE) to treat or diagnose the disease or condition for which approval of the HUD is being sought; or (3) The application contains an untrue statement of material fact or omits material information. (4) The HDE is not accompanied by a statement of either certification or disclosure, or both, as required by part 54 of this chapter. (b) The provisions contained in § 814.42(b), (c), and (d) regarding notification of filing decisions, filing dates, the start of the 75-day review period, and applicant's options in response to FDA refuse to file decisions shall apply to HDE's. | |||
| 21:21:8.0.1.1.11.7.1.8 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | H | Subpart H—Humanitarian Use Devices | § 814.114 Timeframes for reviewing an HDE. | FDA | [63 FR 59221, Nov. 3, 1998] | Within 75 days after receipt of an HDE that is accepted for filing and to which the applicant does not submit a major amendment, FDA shall send the applicant an approval order, an approvable letter, a not approvable letter (under § 814.116), or an order denying approval (under § 814.118). | |||
| 21:21:8.0.1.1.11.7.1.9 | 21 | Food and Drugs | I | H | 814 | PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES | H | Subpart H—Humanitarian Use Devices | § 814.116 Procedures for review of an HDE. | FDA | [61 FR 33244, June 26, 1996, as amended at 63 FR 59221, Nov. 3, 1998; 79 FR 1741, Jan. 10, 2014; 87 FR 2045, Jan. 13, 2022] | (a) Substantive review. FDA will begin substantive review of an HDE after the HDE is accepted for filing under § 814.112. FDA may refer an original HDE application to a panel on its own initiative, and shall do so upon the request of an applicant, unless FDA determines that the application substantially duplicates information previously reviewed by a panel. If the HDE is referred to a panel, the agency shall follow the procedures set forth under § 814.44, with the exception that FDA will complete its review of the HDE and the advisory committee report and recommendations within 75 days from receipt of an HDE that is accepted for filing under § 814.112 or the date of filing as determined under § 814.106, whichever is later. Within the later of these two timeframes, FDA will issue an approval order under paragraph (b) of this section, an approvable letter under paragraph (c) of this section, a not approvable letter under paragraph (d) of this section, or an order denying approval of the application under § 814.118(a). (b) Approval order. FDA will issue to the applicant an order approving an HDE if none of the reasons in § 814.118 for denying approval of the application applies. FDA will approve an application on the basis of draft final labeling if the only deficiencies in the application concern editorial or similar minor deficiencies in the draft final labeling. Such approval will be conditioned upon the applicant incorporating the specified labeling changes exactly as directed and upon the applicant submitting to FDA a copy of the final printed labeling before marketing. The notice of approval of an HDE will be placed on the FDA's home page on the internet ( https://www.fda.gov ) in accordance with the rules and policies applicable to PMAs submitted under § 814.20. Following the issuance of an approval order, data and information in the HDE file will be available for public disclosure in accordance with § 814.9(b) through (h), as applicable. (c) Approvable letter. FDA will send the applicant an approvabl… | |||
| 28:28:2.0.6.5.10.0.127.1 | 28 | Judicial Administration | VIII | 814 | PART 814—SALARY OFFSET PROCEDURES | § 814.1 Purpose and Scope. | CSOSA | (a) Purpose. This part prescribes the Court Services and Offender Supervision Agency's (CSOSA) standards and procedures for the collection of debts owed by CSOSA employees to the United States through voluntary or involuntary Agency salary offset. (b) Scope. (1) This part applies to internal and Government-wide collections of debts, owed by CSOSA employees, through administrative offset from the current pay account of the debtor without his or her consent. (2) The procedures contained in this part do not apply to— (i) Any case where an employee consents to collection through deduction(s) from the employee's Agency pay account; (ii) Debts arising under the Internal Revenue Code (26 U.S.C. 1 et seq. ); (iii) Debts arising under the tariff laws of the United States; (iv) Any case where collection of a debt by salary offset is explicitly provided for or prohibited by another statute ( e.g., travel advances in 5 U.S.C. 5705 and employee training expenses in 5 U.S.C. 4108); or (v) Any other debt excluded by the Federal Claims Collection Standards (FCCS), 31 CFR parts 900 through 904. (3) This part does not preclude a CSOSA employee from requesting waiver of an erroneous payment under 5 U.S.C. 5584, 10 U.S.C. 2774, or 32 U.S.C. 716, or in any way questioning the amount or validity of a debt, in the manner prescribed by the Director. Similarly, this part does not preclude a CSOSA employee from requesting a waiver of the collection of a debt under any other applicable statutory authority. (4) Nothing in this part precludes the compromise of the debt, or the suspension or termination of collection actions, in accordance with 31 U.S.C. 3711 or other applicable statutory authority. | |||||||
| 28:28:2.0.6.5.10.0.127.10 | 28 | Judicial Administration | VIII | 814 | PART 814—SALARY OFFSET PROCEDURES | § 814.10 Method and source of deductions. | CSOSA | (a) Types of deductions. Unless the debtor employee and the Director have agreed to an alternative repayment arrangement under § 814.9, a debt shall be collected in lump sum or by installment deductions at officially established pay intervals from an employee's current pay account. (b) Limitation on amount of deduction. Ordinarily, the size of installment deductions must bear a reasonable relationship to the size of the debt and the employee's ability to pay. However, the amount deducted for any pay period must not exceed 15 percent of the disposable pay from which the deduction is made, unless the employee has agreed in writing to the deduction of a greater amount, as outlined in § 814.10(c) and/or a higher deduction has been ordered by a court under section 124 of Public Law 97-276 (96 Stat. 1195). (c) Duration of deductions —(1) Lump sum. If the amount of the debt is equal to or less than 15 percent of the employee's disposable pay for an officially established pay interval, the debt generally will be collected in one lump-sum deduction. (2) Inability to pay lump sum. If the employee is deemed financially unable to pay in one lump sum or the amount of the debt exceeds 15 percent of the employee's disposable pay for an officially established pay interval, the debt shall be collected in installments. Except as provided in paragraphs (e) and (f) of this section, installment deductions must be made over a period not greater than the anticipated period of active duty or employment. (d) When deductions may begin. (1) Deductions will begin on the date stated in the notice of intent, unless an alternative repayment agreement under § 814.9 has been accepted or the employee has filed a timely request for a hearing. (2) If the employee files a timely petition for hearing as provided in § 814.6, deductions will begin after the hearing official has provided the employee with a hearing and a final written decision has been rendered in favor of the Agency. (e) Liquidation from final check. If an employee r… | |||||||
| 28:28:2.0.6.5.10.0.127.11 | 28 | Judicial Administration | VIII | 814 | PART 814—SALARY OFFSET PROCEDURES | § 814.11 Interest, penalties, and administrative costs. | CSOSA | Debts owed to the Agency shall be assessed interest, penalties and administrative costs in accordance with FCCS, 31 CFR 901.9. | |||||||
| 28:28:2.0.6.5.10.0.127.12 | 28 | Judicial Administration | VIII | 814 | PART 814—SALARY OFFSET PROCEDURES | § 814.12 Non-waiver of rights by payments. | CSOSA | An employee's involuntary payment, of all or any portion of a debt being collected under 5 U.S.C. 5514 must not be construed as a waiver of any rights which the employee may have under 5 U.S.C. 5514 or any other provision of contract or law, unless there are statutory or contractual provisions to the contrary. | |||||||
| 28:28:2.0.6.5.10.0.127.13 | 28 | Judicial Administration | VIII | 814 | PART 814—SALARY OFFSET PROCEDURES | § 814.13 Refunds. | CSOSA | (a) CSOSA will promptly refund amounts paid or deducted under this subpart to the appropriate party, when: (1) A debt is waived or otherwise found not owing to the United States (unless expressly prohibited by statute or regulation); or (2) The employee's paying agency is directed by an administrative or judicial order to refund amounts deducted from his or her current pay. (b) Refunds do not bear interest unless required or permitted by law or contract. | |||||||
| 28:28:2.0.6.5.10.0.127.2 | 28 | Judicial Administration | VIII | 814 | PART 814—SALARY OFFSET PROCEDURES | § 814.2 Definitions. | CSOSA | Administrative offset means withholding funds payable by the United States to, or held by the United States for, a person to satisfy a debt owed by the payee. Agency means an executive department or agency; a military department; the United States Postal Service; the Postal Rate Commission; the United States Senate; the United States House of Representatives; any court, court administrative office, or instrumentality in the judicial or legislative branches of the Government; or a Government Corporation. Creditor agency means the agency to which the debt is owed, including a debt collection center when acting on behalf of a creditor agency in matters pertaining to the collection of a debt (as provided in 5 CFR 550.1110). Day means calendar day. For purposes of computation, the last day of the period will be included unless it is a Saturday, Sunday, or a Federal holiday, in which case the next business day will be considered the last day of the period. Debt means an amount determined by an appropriate official to be owed to the United States from sources which include loans insured or guaranteed by the United States and all other amounts due the United States from fees, leases, rents, royalties, services, sales of real or personal property, overpayments, penalties, damages, interest, fines and forfeitures (except those arising under the Uniform Code of Military Justice), and all other similar sources. Debt collection Center means the Department of the Treasury, Department of Agriculture's National Finance Center or other Government agency or division designated by the Secretary of the Treasury with authority to collect debts on behalf of creditor agencies in accordance with 31 U.S.C. 3711(g). Debtor means a Federal employee who owes a debt to the United States. Delinquent debt means a debt which the debtor does not pay or otherwise resolve by the date specified in the initial demand for payment, or in an applicable written repayment agreement or other instrument, including a post delinquency repaymen… | |||||||
| 28:28:2.0.6.5.10.0.127.3 | 28 | Judicial Administration | VIII | 814 | PART 814—SALARY OFFSET PROCEDURES | § 814.3 Entitlement to notice, hearing, written responses and decisions. | CSOSA | (a) Except as provided in § 814.4, each employee from whom CSOSA proposes to collect a debt using salary offset under this part is entitled to receive from CSOSA: (1) A written notice as described in § 814.5; and (2) An opportunity to petition for a hearing and, if a hearing is given, to receive a written decision from the official within 60 days of holding the hearing on the following issues: (i) The determination concerning the existence or amount of the debt; and (ii) The repayment schedule, if it was not established by written agreement between the employee and CSOSA. (b) [Reserved] | |||||||
| 28:28:2.0.6.5.10.0.127.4 | 28 | Judicial Administration | VIII | 814 | PART 814—SALARY OFFSET PROCEDURES | § 814.4 Exception to entitlement to notice, hearing, written responses, and final decisions. | CSOSA | For internal collections, the provisions of § 814.3 do not apply to: (a) Any adjustment to pay arising out of an employee's election of coverage or a change in coverage under a Federal benefits program requiring periodic deductions from pay, if the amount to be recovered was accumulated over four pay periods or less; (b) A routine intra-agency adjustment of pay that is made to correct an overpayment of pay attributable to clerical or administrative errors or delays in processing pay documents, if the overpayment occurred within the four pay periods preceding the adjustment and, at the time of such adjustment, or as soon thereafter as practical, the individual is provided written notice of the nature and the amount of the adjustment and point of contact for contesting such adjustment; or (c) Any adjustment to collect a debt amounting to $50 or less, if, at the time of such adjustment, or as soon thereafter as practical, the individual is provided written notice of the nature and the amount of the adjustment and a point of contact for contesting such adjustment. | |||||||
| 28:28:2.0.6.5.10.0.127.5 | 28 | Judicial Administration | VIII | 814 | PART 814—SALARY OFFSET PROCEDURES | § 814.5 Notification before deductions begin. | CSOSA | (a) CSOSA and/or a Debt Collection Center will provide employees notification before deductions begin. Except as provided in § 814.4, agency pay deductions under the authority of 5 U.S.C. 5514 must not be made unless the Director (or authorized designee) provides the employee a written notice at least 30 days before any deduction begins. (For debts outstanding more than 10 years on or before June 11, 2009, see also 31 CFR 285.7(d) for additional notification requirements.) The written notice must state at a minimum: (1) CSOSA's determination that a debt is owed, including the origin, nature, and amount of that debt; (2) CSOSA's intention to collect the debt by means of deduction from the employee's current disposable pay account; (3) The frequency and amount of the intended deduction (stated as a fixed dollar amount or as a percentage of pay, not to exceed 15 percent of disposable pay except as provided in § 814.10) and the intention to continue the deductions until the debt is paid in full or otherwise resolved; (4) An explanation of CSOSA's policy concerning interest, penalties, and administrative costs, including a statement that such assessments must be made unless excused in accordance with the FCCS as defined in § 814.2; (5) The employee's right to inspect and copy Government records relating to the debt or, if employee or his or her representative cannot personally inspect the records, to request and receive a copy of such records; (6) If not previously provided, the opportunity (under terms agreeable to CSOSA) to establish a schedule for the voluntary repayment of the debt or to enter into a written agreement to establish a schedule for repayment of the debt in lieu of offset. The agreement must be in writing, signed by both the employee and CSOSA; and documented in CSOSA's files; (7) The employee's right to a hearing conducted by an official arranged by CSOSA (an administrative law judge, or alternatively, a hearing official not under the control of the Director of CSOSA) if a petition is filed as… | |||||||
| 28:28:2.0.6.5.10.0.127.6 | 28 | Judicial Administration | VIII | 814 | PART 814—SALARY OFFSET PROCEDURES | § 814.6 Petitions for hearing. | CSOSA | (a) To request a hearing concerning the existence or amount of the debt or the offset schedule established by the Agency, the employee must send a written petition to the office designated in the notice of intent to offset, see § 814.5(a)(9), within 15 days of receipt of the deduction notice, stating why the employee believes the determination of the Agency concerning the existence or amount of the debt is in error or requesting changes to the proposed deduction frequency and amount. (b) The petition must: (1) Be signed by the employee; (2) Fully identify and explain with reasonable specificity all the facts, evidence, and witnesses, if any, that the employee believes support the employee's position; and (3) Specify whether an oral or paper (documentary) hearing is requested. If an oral hearing is requested, the request should explain why the matter cannot be resolved by review of the documentary evidence alone. | |||||||
| 28:28:2.0.6.5.10.0.127.7 | 28 | Judicial Administration | VIII | 814 | PART 814—SALARY OFFSET PROCEDURES | § 814.7 Petitions for hearing made after time expires. | CSOSA | (a) If the petition for hearing is filed after the 15-day period provided for in § 814.6, the Director may grant the request if the employee can establish that the delay was the result of circumstances beyond the employee's control, or that the employee failed to receive actual notice of the filing deadline. (b) An employee waives the right to a hearing, and will have his or her disposable pay offset in accordance with the offset schedule established by the Agency, if the employee: (1) Fails to file a timely request for a hearing, unless such failure is excused; or (2) Fails to appear at an oral hearing, of which the employee was notified, unless the hearing official determines that the failure to appear was due to circumstances beyond the employee's control. (c) The following procedure is instituted upon a failure to appear at a hearing. (1) In the absence of good cause shown ( e.g., illness), an employee who fails to appear at a hearing shall be deemed, for the purpose of this part, to admit the existence and amount of the debt as described in the notice of intent. (2) If the representative of the creditor agency fails to appear, the hearing official shall proceed with the hearing as scheduled and make a determination based upon oral testimony presented and the documentary evidence submitted by both parties. With the agreement of both parties, the hearing official shall schedule a new hearing date, and both parties shall be given reasonable notice of the time and place of the new hearing. | |||||||
| 28:28:2.0.6.5.10.0.127.8 | 28 | Judicial Administration | VIII | 814 | PART 814—SALARY OFFSET PROCEDURES | § 814.8 Representation at the hearing. | CSOSA | (a) The creditor agency may be represented by legal counsel. (b) The employee may be self-represented or may be represented by an individual of the employee's choosing, at the employee's expense. | |||||||
| 28:28:2.0.6.5.10.0.127.9 | 28 | Judicial Administration | VIII | 814 | PART 814—SALARY OFFSET PROCEDURES | § 814.9 Procedures for hearing and final decisions. | CSOSA | (a) Form of hearings —(1) General. After the employee requests a hearing, the hearing official shall notify the employee of the form of the hearing. If the hearing will be oral, the notice shall set forth the date, time, and location of the hearing. If the hearing will be a review of the written record, the employee shall be notified that he or she should submit evidence and arguments in writing to the hearing official by a specified date, after which the record shall be closed. The date specified shall give the employee reasonable time to submit documentation. (2) Oral hearing. An employee who requests an oral hearing shall be provided an oral hearing, if the hearing official determines that the matter cannot be resolved by review of documentary evidence alone ( e.g., when an issue of credibility or veracity is involved). Where an oral hearing is appropriate, the hearing is not an adversarial adjudication and need not take the form of an evidentiary hearing, e.g., the rules of evidence do not apply. Oral hearings may take the form of, but are not limited to: (i) Informal conferences with the hearing official in which the employee and agency representative will be given full opportunity to present evidence, witnesses, and arguments; (ii) Informal meetings in which the hearing official interviews the employee; or (iii) Formal written submissions with an opportunity for oral presentations. (3) Paper (documentary) hearing. If the hearing official determines that an oral hearing is not necessary, the hearing official will make the determination based upon a review of the available written record. (4) Record. The hearing official shall maintain a summary record of any hearing conducted under this part. Witnesses who testify in oral hearings will do so under oath or affirmation. (b) Written decision —(1) Date of decision. The hearing officer shall issue a written opinion stating his or her decision, based upon documentary evidence and information developed at the hearing, as soon as practicable af… |
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title_number INTEGER,
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chapter TEXT,
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