cfr_sections
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37 rows where part_number = 812 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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| 21:21:8.0.1.1.9.1.1.1 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | A | Subpart A—General Provisions | § 812.1 Scope. | FDA | [45 FR 3751, Jan. 18, 1980, as amended at 59 FR 14366, Mar. 28, 1994; 61 FR 52654, Oct. 7, 1996; 90 FR 55979, Dec. 4, 2025] | (a) The purpose of this part is to encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use, and to that end to maintain optimum freedom for scientific investigators in their pursuit of this purpose. This part provides procedures for the conduct of clinical investigations of devices. An approved investigational device exemption (IDE) permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device. An IDE approved under § 812.30 or considered approved under § 812.2(b) exempts a device from the requirements of the following sections of the Federal Food, Drug, and Cosmetic Act (the act) and the regulations in this chapter issued thereunder: Misbranding under section 502 of the act, registration, listing, and premarket notification under section 510, performance standards under section 514, premarket approval under section 515, a banned device regulation under section 516, records and reports under section 519, restricted device requirements under section 520(e), good manufacturing practice requirements under section 520(f) except for the requirements found in § 820.10(c), if applicable (unless the sponsor states an intention to comply with these requirements under § 812.20(b)(3) or § 812.140(b)(4)(v)) and color additive requirements under section 721. (b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted. | |||
| 21:21:8.0.1.1.9.1.1.2 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | A | Subpart A—General Provisions | § 812.2 Applicability. | FDA | [45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8956, Jan. 27, 1981; 46 FR 14340, Feb. 27, 1981; 53 FR 11252, Apr. 6, 1988; 62 FR 4165, Jan. 29, 1997; 62 FR 12096, Mar. 14, 1997; 88 FR 88249, Dec. 21, 2023] | (a) General. This part applies to all clinical investigations of devices to determine safety and effectiveness, except as provided in paragraph (c) of this section. (b) Abbreviated requirements. The following categories of investigations are considered to have approved applications for IDE's, unless FDA has notified a sponsor under § 812.20(a) that approval of an application is required: (1) An investigation of a device other than a significant risk device, if the device is not a banned device and the sponsor: (i) Labels the device in accordance with § 812.5; (ii) Obtains IRB approval of the investigation after presenting the reviewing IRB with a brief explanation of why the device is not a significant risk device, and maintains such approval; (iii) Ensures that each investigator participating in an investigation of the device obtains from each subject under the investigator's care, informed consent in accordance with part 50 of this chapter. (iv) Complies with the requirements of § 812.46 with respect to monitoring investigations; (v) Maintains the records required under § 812.140(b) (4) and (5) and makes the reports required under § 812.150(b) (1) through (3) and (5) through (10); (vi) Ensures that participating investigators maintain the records required by § 812.140(a)(3)(i) and make the reports required under § 812.150(a) (1), (2), (5), and (7); and (vii) Complies with the prohibitions in § 812.7 against promotion and other practices. (2) An investigation of a device other than one subject to paragraph (e) of this section, if the investigation was begun on or before July 16, 1980, and to be completed, and is completed, on or before January 19, 1981. (c) Exempted investigations. This part, with the exception of § 812.119, does not apply to investigations of the following categories of devices: (1) A device, other than a transitional device, in commercial distribution immediately before May 28, 1976, when used or investigated in accordance with the indications in labeling in effect at that ti… | |||
| 21:21:8.0.1.1.9.1.1.3 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | A | Subpart A—General Provisions | § 812.3 Definitions. | FDA | [45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8956, Jan. 27, 1981; 48 FR 15622, Apr. 12, 1983; 81 FR 70340, Oct. 12, 2016; 83 FR 7385, Feb. 21, 2018; 83 FR 7385, Feb. 21, 2018] | (a) Act means the Federal Food, Drug, and Cosmetic Act (sections 201-901, 52 Stat. 1040 et seq., as amended (21 U.S.C. 301-392)). (b) A custom device means a device within the meaning of section 520(b) of the Federal Food, Drug, and Cosmetic Act. (c) FDA means the Food and Drug Administration. (d) Implant means a device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more. FDA may, in order to protect public health, determine that devices placed in subjects for shorter periods are also “implants” for purposes of this part. (e) Institution means a person, other than an individual, who engages in the conduct of research on subjects or in the delivery of medical services to individuals as a primary activity or as an adjunct to providing residential or custodial care to humans. The term includes, for example, a hospital, retirement home, confinement facility, academic establishment, and device manufacturer. The term has the same meaning as “facility” in section 520(g) of the act. (f) Institutional review board (IRB) means any board, committee, or other group formally designated by an institution to review biomedical research involving subjects and established, operated, and functioning in conformance with part 56. The term has the same meaning as “institutional review committee” in section 520(g) of the act. (g) Investigational device means a device, including a transitional device, that is the object of an investigation. (h) Investigation means a clinical investigation or research involving one or more subjects to determine the safety or effectiveness of a device. (i) Investigator means an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team. (j) Monitor, when used a… | |||
| 21:21:8.0.1.1.9.1.1.4 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | A | Subpart A—General Provisions | § 812.5 Labeling of investigational devices. | FDA | [45 FR 3751, Jan. 18, 1980, as amended at 45 FR 58842, Sept. 5, 1980; 72 FR 73602, Dec. 28, 2007] | (a) Contents. An investigational device or its immediate package shall bear a label with the following information: the name and place of business of the manufacturer, packer, or distributor (in accordance with § 801.1), the quantity of contents, if appropriate, and the following statement: “CAUTION—Investigational device. Limited by Federal (or United States) law to investigational use.” The label or other labeling shall describe all relevant contraindications, hazards, adverse effects, interfering substances or devices, warnings, and precautions. (b) Prohibitions. The labeling of an investigational device shall not bear any statement that is false or misleading in any particular and shall not represent that the device is safe or effective for the purposes for which it is being investigated. (c) Animal research. An investigational device shipped solely for research on or with laboratory animals shall bear on its label the following statement: “CAUTION—Device for investigational use in laboratory animals or other tests that do not involve human subjects.” (d) The appropriate FDA Center Director, according to the procedures set forth in § 801.128 or § 809.11 of this chapter, may grant an exception or alternative to the provisions in paragraphs (a) and (c) of this section, to the extent that these provisions are not explicitly required by statute, for specified lots, batches, or other units of a device that are or will be included in the Strategic National Stockpile. | |||
| 21:21:8.0.1.1.9.1.1.5 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | A | Subpart A—General Provisions | § 812.7 Prohibition of promotion and other practices. | FDA | A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not: (a) Promote or test market an investigational device, until after FDA has approved the device for commercial distribution. (b) Commercialize an investigational device by charging the subjects or investigators for a device a price larger than that necessary to recover costs of manufacture, research, development, and handling. (c) Unduly prolong an investigation. If data developed by the investigation indicate in the case of a class III device that premarket approval cannot be justified or in the case of a class II device that it will not comply with an applicable performance standard or an amendment to that standard, the sponsor shall promptly terminate the investigation. (d) Represent that an investigational device is safe or effective for the purposes for which it is being investigated. | ||||
| 21:21:8.0.1.1.9.1.1.6 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | A | Subpart A—General Provisions | § 812.10 Waivers. | FDA | (a) Request. A sponsor may request FDA to waive any requirement of this part. A waiver request, with supporting documentation, may be submitted separately or as part of an application to the address in § 812.19. (b) FDA action. FDA may by letter grant a waiver of any requirement that FDA finds is not required by the act and is unnecessary to protect the rights, safety, or welfare of human subjects. (c) Effect of request. Any requirement shall continue to apply unless and until FDA waives it. | ||||
| 21:21:8.0.1.1.9.1.1.7 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | A | Subpart A—General Provisions | § 812.18 Import and export requirements. | FDA | [45 FR 3751, Jan. 18, 1980, as amended at 62 FR 26229, May 13, 1997] | (a) Imports. In addition to complying with other requirements of this part, a person who imports or offers for importation an investigational device subject to this part shall be the agent of the foreign exporter with respect to investigations of the device and shall act as the sponsor of the clinical investigation, or ensure that another person acts as the agent of the foreign exporter and the sponsor of the investigation. (b) Exports. A person exporting an investigational device subject to this part shall obtain FDA's prior approval, as required by section 801(e) of the act or comply with section 802 of the act. | |||
| 21:21:8.0.1.1.9.1.1.8 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | A | Subpart A—General Provisions | § 812.19 Address for IDE correspondence. | FDA | [71 FR 42048, July 25, 2006, as amended at 75 FR 20915, Apr. 22, 2010; 80 FR 18094, Apr. 3, 2015; 84 FR 68339, Dec. 16, 2019] | (a) If you are sending an application, supplemental application, report, request for waiver, request for import or export approval, or other correspondence relating to matters covered by this part, you must send the submission to the appropriate address as follows: (1) For devices regulated by the Center for Devices and Radiological Health, send it to the current address displayed on the website https://www.fda.gov/cdrhsubmissionaddress. (2) For devices regulated by the Center for Biologics Evaluation and Research, send it to the current address displayed on the website https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm. (3) For devices regulated by the Center for Drug Evaluation and Research, send it to Central Document Control Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266. (b) You must state on the outside wrapper of each submission what the submission is, for example, an “IDE application,” a “supplemental IDE application,” or a “correspondence concerning an IDE (or an IDE application).” | |||
| 21:21:8.0.1.1.9.2.1.1 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | B | Subpart B—Application and Administrative Action | § 812.20 Application. | FDA | [45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8956, Jan. 27, 1981; 50 FR 16669, Apr. 26, 1985; 53 FR 11252, Apr. 6, 1988; 61 FR 51530, Oct. 2, 1996; 62 FR 40600, July 29, 1997; 64 FR 10942, Mar. 8, 1999; 73 FR 49942, Aug. 25, 2008; 84 FR 68339, Dec. 16, 2019] | (a) Submission. (1) A sponsor shall submit an application to FDA if the sponsor intends to use a significant risk device in an investigation, intends to conduct an investigation that involves an exception from informed consent under § 50.24 of this chapter, or if FDA notifies the sponsor that an application is required for an investigation. (2) A sponsor shall not begin an investigation for which FDA's approval of an application is required until FDA has approved the application. (3) A sponsor shall submit a signed “Application for an Investigational Device Exemption” (IDE application), together with accompanying materials in electronic format, to one of the addresses in § 812.19, and if eCopy by registered mail or by hand. Subsequent correspondence concerning an application or a supplemental application shall be submitted in electronic format and if eCopy by registered mail or by hand. (4)(i) A sponsor shall submit a separate IDE for any clinical investigation involving an exception from informed consent under § 50.24 of this chapter. Such a clinical investigation is not permitted to proceed without the prior written authorization of FDA. FDA shall provide a written determination 30 days after FDA receives the IDE or earlier. (ii) If the investigation involves an exception from informed consent under § 50.24 of this chapter, the sponsor shall prominently identify on the cover sheet that the investigation is subject to the requirements in § 50.24 of this chapter. (b) Contents. An IDE application shall include, in the following order: (1) The name and address of the sponsor. (2) A complete report of prior investigations of the device and an accurate summary of those sections of the investigational plan described in § 812.25(a) through (e) or, in lieu of the summary, the complete plan. The sponsor shall submit to FDA a complete investigational plan and a complete report of prior investigations of the device if no IRB has reviewed them, if FDA has found an IRB's review inadequate, or if FDA requests them.… | |||
| 21:21:8.0.1.1.9.2.1.2 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | B | Subpart B—Application and Administrative Action | § 812.25 Investigational plan. | FDA | The investigational plan shall include, in the following order: (a) Purpose. The name and intended use of the device and the objectives and duration of the investigation. (b) Protocol. A written protocol describing the methodology to be used and an analysis of the protocol demonstrating that the investigation is scientifically sound. (c) Risk analysis. A description and analysis of all increased risks to which subjects will be exposed by the investigation; the manner in which these risks will be minimized; a justification for the investigation; and a description of the patient population, including the number, age, sex, and condition. (d) Description of device. A description of each important component, ingredient, property, and principle of operation of the device and of each anticipated change in the device during the course of the investigation. (e) Monitoring procedures. The sponsor's written procedures for monitoring the investigation and the name and address of any monitor. (f) Labeling. Copies of all labeling for the device. (g) Consent materials. Copies of all forms and informational materials to be provided to subjects to obtain informed consent. (h) IRB information. A list of the names, locations, and chairpersons of all IRB's that have been or will be asked to review the investigation, and a certification of any action taken by any of those IRB's with respect to the investigation. (i) Other institutions. The name and address of each institution at which a part of the investigation may be conducted that has not been identified in paragraph (h) of this section. (j) Additional records and reports. A description of records and reports that will be maintained on the investigation in addition to those prescribed in subpart G. | ||||
| 21:21:8.0.1.1.9.2.1.3 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | B | Subpart B—Application and Administrative Action | § 812.27 Report of prior investigations. | FDA | [45 FR 3751, Jan. 18, 1980, as amended at 50 FR 7518, Feb. 22, 1985; 83 FR 7385, Feb. 21, 2018] | (a) General. The report of prior investigations shall include reports of all prior clinical, animal, and laboratory testing of the device and shall be comprehensive and adequate to justify the proposed investigation. (b) Specific contents. The report also shall include: (1) A bibliography of all publications, whether adverse or supportive, that are relevant to an evaluation of the safety or effectiveness of the device, copies of all published and unpublished adverse information, and, if requested by an IRB or FDA, copies of other significant publications. (2) A summary of all other unpublished information (whether adverse or supportive) in the possession of, or reasonably obtainable by, the sponsor that is relevant to an evaluation of the safety or effectiveness of the device. (3) If information on nonclinical laboratory studies is provided, a statement that all such studies have been conducted in compliance with applicable requirements in the good laboratory practice regulations in part 58, or if any such study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance. Failure or inability to comply with this requirement does not justify failure to provide information on a relevant nonclinical test study. (4)(i) If data from clinical investigations conducted in the United States are provided, a statement that each investigation was conducted in compliance with applicable requirements in the protection of human subjects regulations in part 50 of this chapter, the institutional review boards regulations in part 56 of this chapter, or was not subject to the regulations under § 56.104 or § 56.105, and the investigational device exemptions regulations in this part, or if any such investigation was not conducted in compliance with those regulations, a brief statement of the reason for the noncompliance. Failure or inability to comply with these requirements does not justify failure to provide information on a relevant clinical investigation. (ii) If data fro… | |||
| 21:21:8.0.1.1.9.2.1.4 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | B | Subpart B—Application and Administrative Action | § 812.28 Acceptance of data from clinical investigations conducted outside the United States. | FDA | [83 FR 7386, Feb. 21, 2018] | (a) Acceptance of data from clinical investigations conducted outside the United States to support an IDE or a device marketing application or submission (an application under section 515 or 520(m) of the Federal Food, Drug, and Cosmetic Act, a premarket notification submission under section 510(k) of the Federal Food, Drug, and Cosmetic Act, or a request for De Novo classification under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act). FDA will accept information on a clinical investigation conducted outside the United States to support an IDE or a device marketing application or submission if the investigation is well-designed and well-conducted and the following conditions are met: (1) A statement is provided that the investigation was conducted in accordance with good clinical practice (GCP). For the purposes of this section, GCP is defined as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical investigations in a way that provides assurance that the data and results are credible and accurate and that the rights, safety, and well-being of subjects are protected. GCP includes review and approval (or provision of a favorable opinion) by an independent ethics committee (IEC) before initiating an investigation, continuing review of an ongoing investigation by an IEC, and obtaining and documenting the freely given informed consent of the subject (or a subject's legally authorized representative, if the subject is unable to provide informed consent) before initiating an investigation. GCP does not require informed consent in life-threatening situations when the IEC reviewing the investigation finds, before initiation of the investigation, that informed consent is not feasible and either that the conditions present are consistent with those described in § 50.23 or § 50.24(a) of this chapter, or that the measures described in the protocol or elsewhere will protect the rights, safety, and well-being of subjects. (2) In addition to the … | |||
| 21:21:8.0.1.1.9.2.1.5 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | B | Subpart B—Application and Administrative Action | § 812.30 FDA action on applications. | FDA | [45 FR 3751, Jan. 18, 1980, as amended at 45 FR 58842, Sept. 5, 1980] | (a) Approval or disapproval. FDA will notify the sponsor in writing of the date it receives an application. FDA may approve an investigation as proposed, approve it with modifications, or disapprove it. An investigation may not begin until: (1) Thirty days after FDA receives the application at the address in § 812.19 for the investigation of a device other than a banned device, unless FDA notifies the sponsor that the investigation may not begin; or (2) FDA approves, by order, an IDE for the investigation. (b) Grounds for disapproval or withdrawal. FDA may disapprove or withdraw approval of an application if FDA finds that: (1) There has been a failure to comply with any requirement of this part or the act, any other applicable regulation or statute, or any condition of approval imposed by an IRB or FDA. (2) The application or a report contains an untrue statement of a material fact, or omits material information required by this part. (3) The sponsor fails to respond to a request for additional information within the time prescribed by FDA. (4) There is reason to believe that the risks to the subjects are not outweighed by the anticipated benefits to the subjects and the importance of the knowledge to be gained, or informed consent is inadequate, or the investigation is scientifically unsound, or there is reason to believe that the device as used is ineffective. (5) It is otherwise unreasonable to begin or to continue the investigation owing to the way in which the device is used or the inadequacy of: (i) The report of prior investigations or the investigational plan; (ii) The methods, facilities, and controls used for the manufacturing, processing, packaging, storage, and, where appropriate, installation of the device; or (iii) Monitoring and review of the investigation. (c) Notice of disapproval or withdrawal. If FDA disapproves an application or proposes to withdraw approval of an application, FDA will notify the sponsor in writing. (1) A disapproval order will contain a complete statement … | |||
| 21:21:8.0.1.1.9.2.1.6 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | B | Subpart B—Application and Administrative Action | § 812.35 Supplemental applications. | FDA | [50 FR 25909, June 24, 1985; 50 FR 28932, July 17, 1985, as amended at 61 FR 51531, Oct. 2, 1996; 63 FR 64625, Nov. 23, 1998; 90 FR 55980, Dec. 4, 2025] | (a) Changes in investigational plan —(1) Changes requiring prior approval. Except as described in paragraphs (a)(2) through (a)(4) of this section, a sponsor must obtain approval of a supplemental application under § 812.30(a), and IRB approval when appropriate (see §§ 56.110 and 56.111 of this chapter), prior to implementing a change to an investigational plan. If a sponsor intends to conduct an investigation that involves an exception to informed consent under § 50.24 of this chapter, the sponsor shall submit a separate investigational device exemption (IDE) application in accordance with § 812.20(a). (2) Changes effected for emergency use. The requirements of paragraph (a)(1) of this section regarding FDA approval of a supplement do not apply in the case of a deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency. Such deviation shall be reported to FDA within 5-working days after the sponsor learns of it (see § 812.150(a)(4)). (3) Changes effected with notice to FDA within 5 days. A sponsor may make certain changes without prior approval of a supplemental application under paragraph (a)(1) of this section if the sponsor determines that these changes meet the criteria described in paragraphs (a)(3)(i) and (a)(3)(ii) of this section, on the basis of credible information defined in paragraph (a)(3)(iii) of this section, and the sponsor provides notice to FDA within 5-working days of making these changes. (i) Developmental changes. The requirements in paragraph (a)(1) of this section regarding FDA approval of a supplement do not apply to developmental changes in the device (including manufacturing changes) that do not constitute a significant change in design or basic principles of operation and that are made in response to information gathered during the course of an investigation. (ii) Changes to clinical protocol. The requirements in paragraph (a)(1) of this section regarding FDA approval of a supplement do not apply to changes to clinical… | |||
| 21:21:8.0.1.1.9.2.1.7 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | B | Subpart B—Application and Administrative Action | § 812.36 Treatment use of an investigational device. | FDA | [62 FR 48947, Sept. 18, 1997] | (a) General. A device that is not approved for marketing may be under clinical investigation for a serious or immediately life-threatening disease or condition in patients for whom no comparable or satisfactory alternative device or other therapy is available. During the clinical trial or prior to final action on the marketing application, it may be appropriate to use the device in the treatment of patients not in the trial under the provisions of a treatment investigational device exemption (IDE). The purpose of this section is to facilitate the availability of promising new devices to desperately ill patients as early in the device development process as possible, before general marketing begins, and to obtain additional data on the device's safety and effectiveness. In the case of a serious disease, a device ordinarily may be made available for treatment use under this section after all clinical trials have been completed. In the case of an immediately life-threatening disease, a device may be made available for treatment use under this section prior to the completion of all clinical trials. For the purpose of this section, an “immediately life-threatening” disease means a stage of a disease in which there is a reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment. For purposes of this section, “treatment use”of a device includes the use of a device for diagnostic purposes. (b) Criteria. FDA shall consider the use of an investigational device under a treatment IDE if: (1) The device is intended to treat or diagnose a serious or immediately life-threatening disease or condition; (2) There is no comparable or satisfactory alternative device or other therapy available to treat or diagnose that stage of the disease or condition in the intended patient population; (3) The device is under investigation in a controlled clinical trial for the same use under an approved IDE, or such clinical trials have been completed; and (4) The sp… | |||
| 21:21:8.0.1.1.9.2.1.8 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | B | Subpart B—Application and Administrative Action | § 812.38 Confidentiality of data and information. | FDA | [45 FR 3751, Jan. 18, 1980, as amended at 53 FR 11253, Apr. 6, 1988; 61 FR 51531, Oct. 2, 1996; 88 FR 16880, Mar. 21, 2023] | (a) Existence of IDE. FDA will not disclose the existence of an IDE unless its existence has previously been publicly disclosed or acknowledged, until FDA approves an application for premarket approval of the device subject to the IDE; or a notice of completion of a product development protocol for the device has become effective. (b) Availability of summaries or data. (1) FDA will make publicly available, upon request, a detailed summary of information concerning the safety and effectiveness of the device that was the basis for an order approving, disapproving, or withdrawing approval of an application for an IDE for a banned device. The summary shall include information on any adverse effect on health caused by the device. (2) If a device is a banned device or if the existence of an IDE has been publicly disclosed or acknowledged, data or information contained in the file is not available for public disclosure before approval of an application for premarket approval or the effective date of a notice of completion of a product development protocol except as provided in this section. FDA may, in its discretion, disclose a summary of selected portions of the safety and effectiveness data, that is, clinical, animal, or laboratory studies and tests of the device, for public consideration of a specific pending issue. (3) If the existence of an IDE file has not been publicly disclosed or acknowledged, no data or information in the file are available for public disclosure except as provided in paragraphs (b)(1) and (c) of this section. (4) Notwithstanding paragraph (b)(2) 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 FDA-1995-S-0036 in the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, for investigations involving an exception from informed consent under § 50.24 of this chapter. Persons wishing to request this information shall submit a request un… | |||
| 21:21:8.0.1.1.9.3.1.1 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | C | Subpart C—Responsibilities of Sponsors | § 812.40 General responsibilities of sponsors. | FDA | Sponsors are responsible for selecting qualified investigators and providing them with the information they need to conduct the investigation properly, ensuring proper monitoring of the investigation, ensuring that IRB review and approval are obtained, submitting an IDE application to FDA, and ensuring that any reviewing IRB and FDA are promptly informed of significant new information about an investigation. Additional responsibilities of sponsors are described in subparts B and G. | ||||
| 21:21:8.0.1.1.9.3.1.2 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | C | Subpart C—Responsibilities of Sponsors | § 812.42 FDA and IRB approval. | FDA | [46 FR 8957, Jan. 27, 1981] | A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both approved the application or supplemental application relating to the investigation or part of an investigation. | |||
| 21:21:8.0.1.1.9.3.1.3 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | C | Subpart C—Responsibilities of Sponsors | § 812.43 Selecting investigators and monitors. | FDA | [45 FR 3751, Jan. 18, 1980, as amended at 63 FR 5253, Feb. 2, 1998] | (a) Selecting investigators. A sponsor shall select investigators qualified by training and experience to investigate the device. (b) Control of device. A sponsor shall ship investigational devices only to qualified investigators participating in the investigation. (c) Obtaining agreements. A sponsor shall obtain from each participating investigator a signed agreement that includes: (1) The investigator's curriculum vitae. (2) Where applicable, a statement of the investigator's relevant experience, including the dates, location, extent, and type of experience. (3) If the investigator was involved in an investigation or other research that was terminated, an explanation of the circumstances that led to termination. (4) A statement of the investigator's commitment to: (i) Conduct the investigation in accordance with the agreement, the investigational plan, this part and other applicable FDA regulations, and conditions of approval imposed by the reviewing IRB or FDA; (ii) Supervise all testing of the device involving human subjects; and (iii) Ensure that the requirements for obtaining informed consent are met. (5) Sufficient accurate financial disclosure information to allow the sponsor to submit a complete and accurate certification or disclosure statement as required under part 54 of this chapter. The sponsor shall obtain a commitment from the clinical investigator to promptly update this information if any relevant changes occur during the course of the investigation and for 1 year following completion of the study. This information shall not be submitted in an investigational device exemption application, but shall be submitted in any marketing application involving the device. (d) Selecting monitors. A sponsor shall select monitors qualified by training and experience to monitor the investigational study in accordance with this part and other applicable FDA regulations. | |||
| 21:21:8.0.1.1.9.3.1.4 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | C | Subpart C—Responsibilities of Sponsors | § 812.45 Informing investigators. | FDA | A sponsor shall supply all investigators participating in the investigation with copies of the investigational plan and the report of prior investigations of the device. | ||||
| 21:21:8.0.1.1.9.3.1.5 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | C | Subpart C—Responsibilities of Sponsors | § 812.46 Monitoring investigations. | FDA | (a) Securing compliance. A sponsor who discovers that an investigator is not complying with the signed agreement, the investigational plan, the requirements of this part or other applicable FDA regulations, or any conditions of approval imposed by the reviewing IRB or FDA shall promptly either secure compliance, or discontinue shipments of the device to the investigator and terminate the investigator's participation in the investigation. A sponsor shall also require such an investigator to dispose of or return the device, unless this action would jeopardize the rights, safety, or welfare of a subject. (b) Unanticipated adverse device effects. (1) A sponsor shall immediately conduct an evaluation of any unanticipated adverse device effect. (2) A sponsor who determines that an unanticipated adverse device effect presents an unreasonable risk to subjects shall terminate all investigations or parts of investigations presenting that risk as soon as possible. Termination shall occur not later than 5 working days after the sponsor makes this determination and not later than 15 working days after the sponsor first received notice of the effect. (c) Resumption of terminated studies. If the device is a significant risk device, a sponsor may not resume a terminated investigation without IRB and FDA approval. If the device is not a significant risk device, a sponsor may not resume a terminated investigation without IRB approval and, if the investigation was terminated under paragraph (b)(2) of this section, FDA approval. | ||||
| 21:21:8.0.1.1.9.3.1.6 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | C | Subpart C—Responsibilities of Sponsors | § 812.47 Emergency research under § 50.24 of this chapter. | FDA | [61 FR 51531, Oct. 2, 1996, as amended at 64 FR 10943, Mar. 8, 1999; 88 FR 16880, Mar. 21, 2023] | (a) The sponsor shall monitor the progress of all investigations involving an exception from informed consent under § 50.24 of this chapter. When the sponsor receives from the IRB information concerning the public disclosures under § 50.24(a)(7)(ii) and (iii) of this chapter, the sponsor shall promptly submit to the IDE file and to Docket Number FDA-1995-S-0036 in the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, copies of the information that was disclosed, identified by the IDE number. (b) The sponsor also shall monitor such investigations to determine when an IRB determines that it cannot approve the research because it does not meet the criteria in the exception in § 50.24(a) of this chapter or because of other relevant ethical concerns. The sponsor promptly shall provide this information in writing to FDA, investigators who are asked to participate in this or a substantially equivalent clinical investigation, and other IRB's that are asked to review this or a substantially equivalent investigation. | |||
| 21:21:8.0.1.1.9.4.1.1 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | D | Subpart D—IRB Review and Approval | § 812.60 IRB composition, duties, and functions. | FDA | [46 FR 8957, Jan. 27, 1981] | An IRB reviewing and approving investigations under this part shall comply with the requirements of part 56 in all respects, including its composition, duties, and functions. | |||
| 21:21:8.0.1.1.9.4.1.2 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | D | Subpart D—IRB Review and Approval | § 812.62 IRB approval. | FDA | [46 FR 8957, Jan. 27, 1981] | (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all investigations covered by this part. (b) If no IRB exists or if FDA finds that an IRB's review is inadequate, a sponsor may submit an application to FDA. | |||
| 21:21:8.0.1.1.9.4.1.3 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | D | Subpart D—IRB Review and Approval | § 812.64 IRB's continuing review. | FDA | [46 FR 8957, Jan. 27, 1981] | The IRB shall conduct its continuing review of an investigation in accordance with part 56. | |||
| 21:21:8.0.1.1.9.4.1.4 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | D | Subpart D—IRB Review and Approval | § 812.65 [Reserved] | FDA | |||||
| 21:21:8.0.1.1.9.4.1.5 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | D | Subpart D—IRB Review and Approval | § 812.66 Significant risk device determinations. | FDA | [46 FR 8957, Jan. 27, 1981] | If an IRB determines that an investigation, presented for approval under § 812.2(b)(1)(ii), involves a significant risk device, it shall so notify the investigator and, where appropriate, the sponsor. A sponsor may not begin the investigation except as provided in § 812.30(a). | |||
| 21:21:8.0.1.1.9.5.1.1 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | E | Subpart E—Responsibilities of Investigators | § 812.100 General responsibilities of investigators. | FDA | [45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8957, Jan. 27, 1981] | An investigator is responsible for ensuring that an investigation is conducted according to the signed agreement, the investigational plan and applicable FDA regulations, for protecting the rights, safety, and welfare of subjects under the investigator's care, and for the control of devices under investigation. An investigator also is responsible for ensuring that informed consent is obtained in accordance with part 50 of this chapter. Additional responsibilities of investigators are described in subpart G. | |||
| 21:21:8.0.1.1.9.5.1.2 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | E | Subpart E—Responsibilities of Investigators | § 812.110 Specific responsibilities of investigators. | FDA | [45 FR 3751, Jan. 18, 1980, as amended at 63 FR 5253, Feb. 2, 1998] | (a) Awaiting approval. An investigator may determine whether potential subjects would be interested in participating in an investigation, but shall not request the written informed consent of any subject to participate, and shall not allow any subject to participate before obtaining IRB and FDA approval. (b) Compliance. An investigator shall conduct an investigation in accordance with the signed agreement with the sponsor, the investigational plan, this part and other applicable FDA regulations, and any conditions of approval imposed by an IRB or FDA. (c) Supervising device use. An investigator shall permit an investigational device to be used only with subjects under the investigator's supervision. An investigator shall not supply an investigational device to any person not authorized under this part to receive it. (d) Financial disclosure. A clinical investigator shall disclose to the sponsor sufficient accurate financial information to allow the applicant to submit complete and accurate certification or disclosure statements required under part 54 of this chapter. The investigator shall promptly update this information if any relevant changes occur during the course of the investigation and for 1 year following completion of the study. (e) Disposing of device. Upon completion or termination of a clinical investigation or the investigator's part of an investigation, or at the sponsor's request, an investigator shall return to the sponsor any remaining supply of the device or otherwise dispose of the device as the sponsor directs. | |||
| 21:21:8.0.1.1.9.5.1.3 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | E | Subpart E—Responsibilities of Investigators | § 812.119 Disqualification of a clinical investigator. | FDA | [77 FR 25360, Apr. 30, 2012] | (a) If FDA has information indicating that an investigator (including a sponsor-investigator) has repeatedly or deliberately failed to comply with the requirements of this part, part 50, or part 56 of this chapter, or has repeatedly or deliberately submitted to FDA or to the sponsor false information in any required report, the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, or the Center for Drug Evaluation and Research will furnish the investigator written notice of the matter complained of and offer the investigator an opportunity to explain the matter in writing, or, at the option of the investigator, in an informal conference. If an explanation is offered and accepted by the applicable Center, the Center will discontinue the disqualification proceeding. If an explanation is offered but not accepted by the applicable Center, the investigator will be given an opportunity for a regulatory hearing under part 16 of this chapter on the question of whether the investigator is eligible to receive test articles under this part and eligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA. (b) After evaluating all available information, including any explanation presented by the investigator, if the Commissioner determines that the investigator has repeatedly or deliberately failed to comply with the requirements of this part, part 50, or part 56 of this chapter, or has repeatedly or deliberately submitted to FDA or to the sponsor false information in any required report, the Commissioner will notify the investigator, the sponsor of any investigation in which the investigator has been named as a participant, and the reviewing investigational review boards (IRBs) that the investigator is not eligible to receive test articles under this part. The notification to the investigator, sponsor and IRBs will provide a statement of the basis for such determination. The notification also will explain … | |||
| 21:21:8.0.1.1.9.7.1.1 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | G | Subpart G—Records and Reports | § 812.140 Records. | FDA | [45 FR 3751, Jan. 18, 1980, as amended at 45 FR 58843, Sept. 5, 1980; 46 FR 8957, Jan. 27, 1981; 61 FR 57280, Nov. 5, 1996; 63 FR 5253, Feb. 2, 1998; 83 FR 7387, Feb. 21, 2018; 83 FR 7387, Feb. 21, 2018] | (a) Investigator records. A participating investigator shall maintain the following accurate, complete, and current records relating to the investigator's participation in an investigation: (1) All correspondence with another investigator, an IRB, the sponsor, a monitor, or FDA, including required reports. (2) Records of receipt, use or disposition of a device that relate to: (i) The type and quantity of the device, the dates of its receipt, and the batch number or code mark. (ii) The names of all persons who received, used, or disposed of each device. (iii) Why and how many units of the device have been returned to the sponsor, repaired, or otherwise disposed of. (3) Records of each subject's case history and exposure to the device. Case histories include the case report forms and supporting data including, for example, signed and dated consent forms and medical records including, for example, progress notes of the physician, the individual's hospital chart(s), and the nurses' notes. Such records shall include: (i) Documents evidencing informed consent and, for any use of a device by the investigator without informed consent, any written concurrence of a licensed physician and a brief description of the circumstances justifying the failure to obtain informed consent. The case history for each individual shall document that informed consent was obtained prior to participation in the study. (ii) All relevant observations, including records concerning adverse device effects (whether anticipated or unanticipated), information and data on the condition of each subject upon entering, and during the course of, the investigation, including information about relevant previous medical history and the results of all diagnostic tests. (iii) A record of the exposure of each subject to the investigational device, including the date and time of each use, and any other therapy. (4) The protocol, with documents showing the dates of and reasons for each deviation from the protocol. (5) Any other records that FDA requ… | |||
| 21:21:8.0.1.1.9.7.1.2 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | G | Subpart G—Records and Reports | § 812.145 Inspections. | FDA | (a) Entry and inspection. A sponsor or an investigator who has authority to grant access shall permit authorized FDA employees, at reasonable times and in a reasonable manner, to enter and inspect any establishment where devices are held (including any establishment where devices are manufactured, processed, packed, installed, used, or implanted or where records of results from use of devices are kept). (b) Records inspection. A sponsor, IRB, or investigator, or any other person acting on behalf of such a person with respect to an investigation, shall permit authorized FDA employees, at reasonable times and in a reasonable manner, to inspect and copy all records relating to an investigation. (c) Records identifying subjects. An investigator shall permit authorized FDA employees to inspect and copy records that identify subjects, upon notice that FDA has reason to suspect that adequate informed consent was not obtained, or that reports required to be submitted by the investigator to the sponsor or IRB have not been submitted or are incomplete, inaccurate, false, or misleading. | ||||
| 21:21:8.0.1.1.9.7.1.3 | 21 | Food and Drugs | I | H | 812 | PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS | G | Subpart G—Records and Reports | § 812.150 Reports. | FDA | [45 FR 3751, Jan. 18, 1980, as amended at 45 FR 58843, Sept. 5, 1980; 48 FR 15622, Apr. 12, 1983; 62 FR 48948, Sept. 18, 1997] | (a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports: (1) Unanticipated adverse device effects. An investigator shall submit to the sponsor and to the reviewing IRB a report of any unanticipated adverse device effect occurring during an investigation as soon as possible, but in no event later than 10 working days after the investigator first learns of the effect. (2) Withdrawal of IRB approval. An investigator shall report to the sponsor, within 5 working days, a withdrawal of approval by the reviewing IRB of the investigator's part of an investigation. (3) Progress. An investigator shall submit progress reports on the investigation to the sponsor, the monitor, and the reviewing IRB at regular intervals, but in no event less often than yearly. (4) Deviations from the investigational plan. An investigator shall notify the sponsor and the reviewing IRB (see § 56.108(a) (3) and (4)) of any deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency. Such notice shall be given as soon as possible, but in no event later than 5 working days after the emergency occurred. Except in such an emergency, prior approval by the sponsor is required for changes in or deviations from a plan, and if these changes or deviations may affect the scientific soundness of the plan or the rights, safety, or welfare of human subjects, FDA and IRB in accordance with § 812.35(a) also is required. (5) Informed consent. If an investigator uses a device without obtaining informed consent, the investigator shall report such use to the sponsor and the reviewing IRB within 5 working days after the use occurs. (6) Final report. An investigator shall, within 3 months after termination or completion of the investigation or the investigator's part of the investigation, submit a final report to the sponsor and the reviewing IRB. (7) Other. An investigator shall, upon request by a reviewing IRB or FDA, provide acc… | |||
| 28:28:2.0.6.5.8.0.127.1 | 28 | Judicial Administration | VIII | 812 | PART 812—COLLECTION AND USE OF DNA INFORMATION | § 812.1 Purpose. | CSOSA | The Court Services and Offender Supervision Agency for the District of Columbia (“CSOSA”) cooperates with other federal agencies to ensure that DNA samples from offenders are appropriately furnished to the Federal Bureau of Investigation (“FBI”) for DNA analysis. The results of the DNA analyses are to be included in the Combined DNA Index System (“CODIS”). | |||||||
| 28:28:2.0.6.5.8.0.127.2 | 28 | Judicial Administration | VIII | 812 | PART 812—COLLECTION AND USE OF DNA INFORMATION | § 812.2 Individuals subject to DNA collection. | CSOSA | CSOSA is responsible for collecting a DNA sample from each individual under its supervision who is, or has been, convicted of a qualifying District of Columbia Code offense. Qualifying District of Columbia Code offenses were designated by the Council of the District of Columbia in the “DNA Sample Collection Act of 2001.” CSOSA provides a listing of these offenses in the Appendix to this part. The list is presented for informational purposes only. Any future revision to the District of Columbia Code sections designating the qualifying offenses will be effective notwithstanding the timing of a conforming revision of the Appendix by CSOSA. CSOSA may choose not to collect a sample from an individual if it determines that CODIS already contains a DNA analysis for the individual. | |||||||
| 28:28:2.0.6.5.8.0.127.3 | 28 | Judicial Administration | VIII | 812 | PART 812—COLLECTION AND USE OF DNA INFORMATION | § 812.3 Coordination with the Federal Bureau of Prisons. | CSOSA | (a) CSOSA will coordinate with the Federal Bureau of Prisons in order to obtain documentation regarding the collection of a DNA sample when the Federal Bureau of Prisons releases an inmate to CSOSA's supervision or as requested by CSOSA. (b) CSOSA shall provide the Federal Bureau of Prisons with documentation regarding the collection of a DNA sample from a District of Columbia Code offender when CSOSA returns the District of Columbia Code offender to the custody of the Federal Bureau of Prisons or as requested by the Federal Bureau of Prisons. | |||||||
| 28:28:2.0.6.5.8.0.127.4 | 28 | Judicial Administration | VIII | 812 | PART 812—COLLECTION AND USE OF DNA INFORMATION | § 812.4 Collection procedures. | CSOSA | [67 FR 54100, Aug. 21, 2002, as amended at 68 FR 19742, Apr. 22, 2003] | (a) DNA samples will be collected, handled, preserved, and submitted to the FBI in accordance with FBI guidelines. (b) CSOSA has the authority to use such means as are reasonably necessary to collect a sample from an individual who refuses to cooperate in the collection of the sample. Unless CSOSA determines that there are mitigating circumstances, CSOSA will consider that an individual is refusing to cooperate if: (1) The individual is being ordered or transferred to CSOSA's supervision, but fails to report to CSOSA for collection of the sample within 15 business days of being sentenced to probation or being discharged from a correctional institution; or (2) The individual is already under CSOSA supervision and has been notified by his or her Community Supervision Officer of the time to report for collection of the sample, but fails to report for collection of the sample; or (3) The individual has reported to CSOSA for collection of the sample, but fails to provide the sample after being given a minimum of one hour to do so; or (4) The individual specifically states that he or she will not cooperate. (c) When an individual has refused to cooperate in the collection of the sample, CSOSA deems the following to be reasonably necessary means for obtaining the sample: (1) Impose administrative sanctions; (2) Request a revocation hearing by the releasing authority; and/or (3) Refer the individual who refuses to cooperate for criminal prosecution for a class A misdemeanor pursuant to section 4(a)(5) of the DNA Analysis Backlog Elimination Act of 2000 (42 U.S.C. 14135b(a)(5)). |
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