cfr_sections
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23 rows where part_number = 900 and title_number = 21 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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| 21:21:8.0.1.2.36.1.1.1 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | A | Subpart A—Accreditation | § 900.1 Scope. | FDA | The regulations set forth in this part implement the Mammography Quality Standards Act (MQSA) (42 U.S.C. 263b). Subpart A of this part establishes procedures whereby an entity can apply to become a Food and Drug Administration (FDA)-approved accreditation body to accredit facilities to be eligible to perform screening or diagnostic mammography services. Subpart A further establishes requirements and standards for accreditation bodies to ensure that all mammography facilities under the jurisdiction of the United States are adequately and consistently evaluated for compliance with national quality standards for mammography. Subpart B of this part establishes minimum national quality standards for mammography facilities to ensure safe, reliable, and accurate mammography. The regulations set forth in this part do not apply to facilities of the Department of Veterans Affairs. | ||||
| 21:21:8.0.1.2.36.1.1.2 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | A | Subpart A—Accreditation | § 900.2 Definitions. | FDA | [62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 63 FR 56558, Oct. 22, 1998; 64 FR 32407, June 17, 1999; 67 FR 5467, Feb. 6, 2002; 88 FR 15168, Mar. 10, 2023] | The following definitions apply to subparts A, B, and C of this part: (a) Accreditation body or body means an entity that has been approved by FDA under § 900.3(d) to accredit mammography facilities. (b) Action limits or action levels means the minimum and maximum values of a quality assurance measurement that can be interpreted as representing acceptable performance with respect to the parameter being tested. Values less than the minimum or greater than the maximum action limit or level indicate that corrective action must be taken by the facility. Action limits or levels are also sometimes called control limits or levels. (c) Adverse event means an undesirable experience associated with mammography activities within the scope of 42 U.S.C. 263b. Adverse events include but are not limited to: (1) Poor image quality; (2) Failure to send mammography reports within 30 days to the referring healthcare provider or in a timely manner to the self-referred patient; and (3) Use of personnel that do not meet the applicable requirements of § 900.12(a). (d) Air kerma means kerma in a given mass of air. The unit used to measure the quantity of air kerma is the Gray (Gy). For X-rays with energies less than 300 kiloelectron volts (keV), 1 Gy = 100 rad. In air, 1 Gy of absorbed dose is delivered by 114 roentgens (R) of exposure. (e) Breast implant means a prosthetic device implanted in the breast. (f) Calendar quarter means any one of the following time periods during a given year: January 1 through March 31, April 1 through June 30, July 1 through September 30, or October 1 through December 31. (g) Category I means medical educational activities that have been designated as Category I by the Accreditation Council for Continuing Medical Education (ACCME), the American Osteopathic Association (AOA), a state medical society, or an equivalent organization. (h) Certificate means the certificate described in § 900.11(a). (i) Certification means the process of approval of a facility by FDA or a certif… | |||
| 21:21:8.0.1.2.36.1.1.3 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | A | Subpart A—Accreditation | § 900.3 Application for approval as an accreditation body. | FDA | [62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 83 FR 13864, Apr. 2, 2018; 85 FR 18443, Apr. 2, 2020] | (a) Eligibility. Private nonprofit organizations or State agencies capable of meeting the requirements of this subpart A may apply for approval as accreditation bodies. (b) Application for initial approval. (1) An applicant seeking initial FDA approval as an accreditation body shall inform the Division of Mammography Quality Standards, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3621, Silver Spring, MD 20993, Attn: Program Management Branch, of its desire to be approved as an accreditation body and of its requested scope of authority. (2) Following receipt of the request, FDA will provide the applicant with additional information to aid in submission of an application for approval as an accreditation body. (3) The applicant shall furnish to FDA, at the address in § 900.3(b)(1), three copies of an application containing the following information, materials, and supporting documentation: (i) Name, address, and phone number of the applicant and, if the applicant is not a State agency, evidence of nonprofit status (i.e., of fulfilling Internal Revenue Service requirements as a nonprofit organization); (ii) Detailed description of the accreditation standards the applicant will require facilities to meet and a discussion substantiating their equivalence to FDA standards required under § 900.12; (iii) Detailed description of the applicant's accreditation review and decisionmaking process, including: (A) Procedures for performing accreditation and reaccreditation clinical image review in accordance with § 900.4(c), random clinical image reviews in accordance with § 900.4(f), and additional mammography review in accordance with § 900.12(j); (B) Procedures for performing phantom image review; (C) Procedures for assessing mammography equipment evaluations and surveys; (D) Procedures for initiating and performing onsite visits to facilities; (E) Procedures for assessing facility personnel qualifications; (F) Copies of the accreditation appl… | |||
| 21:21:8.0.1.2.36.1.1.4 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | A | Subpart A—Accreditation | § 900.4 Standards for accreditation bodies. | FDA | [62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 64 FR 32407, June 17, 1999; 88 FR 15168, Mar. 10, 2023] | (a) Code of conduct and general responsibilities. The accreditation body shall accept the following responsibilities in order to ensure safe and accurate mammography at the facilities it accredits and shall perform these responsibilities in a manner that ensures the integrity and impartiality of accreditation body actions. (1)(i) When an accreditation body receives or discovers information that suggests inadequate image quality, or upon request by FDA, the accreditation body shall review a facility's clinical images or other aspects of a facility's practice to assist FDA in determining whether or not the facility's practice poses a serious risk to human health. Such reviews are in addition to the evaluation an accreditation body performs as part of the initial accreditation or renewal process for facilities. (ii) If review by the accreditation body demonstrates that a problem does exist with respect to image quality or other aspects of a facility's compliance with quality standards, or upon request by FDA, the accreditation body shall require or monitor corrective actions, or suspend or revoke accreditation of the facility. (2) The accreditation body shall inform FDA as soon as possible but in no case longer than 2 business days after becoming aware of equipment or practices that pose a serious risk to human health. (3) The accreditation body shall establish and administer a quality assurance (QA) program that has been approved by FDA in accordance with § 900.3(d) or paragraph (a)(8) of this section. Such quality assurance program shall: (i) Include requirements for clinical image review and phantom image review; (ii) Ensure that clinical and phantom images are evaluated consistently and accurately; and (iii) Specify the methods and frequency of training and evaluation for clinical and phantom image reviewers, and the bases and procedures for removal of such reviewers. (4) The accreditation body shall establish measures that FDA has approved in accordance with § 900.3(d) or paragraph (a)(8) of this sect… | |||
| 21:21:8.0.1.2.36.1.1.5 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | A | Subpart A—Accreditation | § 900.5 Evaluation. | FDA | FDA shall evaluate annually the performance of each accreditation body. Such evaluation shall include an assessment of the reports of FDA or State inspections of facilities accredited by the body as well as any additional information deemed relevant by FDA that has been provided by the accreditation body or other sources or has been required by FDA as part of its oversight initiatives. The evaluation shall include a determination of whether there are major deficiencies in the accreditation body's performance that, if not corrected, would warrant withdrawal of the approval of the accreditation body under the provisions of § 900.6. | ||||
| 21:21:8.0.1.2.36.1.1.6 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | A | Subpart A—Accreditation | § 900.6 Withdrawal of approval. | FDA | If FDA determines, through the evaluation activities of § 900.5, or through other means, that an accreditation body is not in substantial compliance with this subpart, FDA may initiate the following actions: (a) Major deficiencies. If FDA determines that an accreditation body has failed to perform a major accreditation function satisfactorily, has demonstrated willful disregard for public health, has violated the code of conduct, has committed fraud, or has submitted material false statements to the agency, FDA may withdraw its approval of that accreditation body. (1) FDA shall notify the accreditation body of the agency's action and the grounds on which the approval was withdrawn. (2) An accreditation body that has lost its approval shall notify facilities accredited or seeking accreditation by it that its approval has been withdrawn. Such notification shall be made within a time period and in a manner approved by FDA. (b) Minor deficiencies. If FDA determines that an accreditation body has demonstrated deficiencies in performing accreditation functions and responsibilities that are less serious or more limited than the deficiencies in paragraph (a) of this section, FDA shall notify the body that it has a specified period of time to take particular corrective measures directed by FDA or to submit to FDA for approval the body's own plan of corrective action addressing the minor deficiencies. FDA may place the body on probationary status for a period of time determined by FDA, or may withdraw approval of the body as an accreditation body if corrective action is not taken. (1) If FDA places an accreditation body on probationary status, the body shall notify all facilities accredited or seeking accreditation by it of its probationary status within a time period and in a manner approved by FDA. (2) Probationary status shall remain in effect until such time as the body can demonstrate to the satisfaction of FDA that it has successfully implemented or is implementing the corrective action plan within the esta… | ||||
| 21:21:8.0.1.2.36.1.1.7 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | A | Subpart A—Accreditation | § 900.7 Hearings. | FDA | (a) Opportunities to challenge final adverse actions taken by FDA regarding approval or reapproval of accreditation bodies, withdrawal of approval of accreditation bodies, or rejection of a proposed fee for accreditation shall be communicated through notices of opportunity for informal hearings in accordance with part 16 of this chapter. (b) A facility that has been denied accreditation is entitled to an appeals process from the accreditation body. The appeals process shall be specified in writing by the accreditation body and shall have been approved by FDA in accordance with § 900.3(d) or § 900.4(a)(8). (c) A facility that cannot achieve satisfactory resolution of an adverse accreditation decision through the accreditation body's appeals process may appeal to FDA for reconsideration in accordance with § 900.15. | ||||
| 21:21:8.0.1.2.36.1.1.8 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | A | Subpart A—Accreditation | §§ 900.8-900.9 [Reserved] | FDA | |||||
| 21:21:8.0.1.2.36.2.1.1 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | B | Subpart B—Quality Standards and Certification | § 900.10 Applicability. | FDA | The provisions of subpart B are applicable to all facilities under the regulatory jurisdiction of the United States that provide mammography services, with the exception of the Department of Veterans Affairs. | ||||
| 21:21:8.0.1.2.36.2.1.2 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | B | Subpart B—Quality Standards and Certification | § 900.11 Requirements for certification. | FDA | [62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 83 FR 13864, Apr. 2, 2018; 88 FR 15168, Mar. 10, 2023] | (a) General. After October 1, 1994, a certificate issued by FDA is required for lawful operation of all mammography facilities subject to the provisions of this subpart. To obtain a certificate from FDA, facilities are required to meet the quality standards in § 900.12 and to be accredited by an approved accreditation body or other entity as designated by FDA. (b) Application —(1) Certificates. (i) In order to qualify for a certificate, a facility must apply to an FDA-approved accreditation body, or to another entity designated by FDA. The facility shall submit to such body or entity the information required in 42 U.S.C. 263b(d)(1). (ii) Following the agency's receipt of the accreditation body's decision to accredit a facility, or an equivalent decision by another entity designated by FDA, the agency may issue a certificate to the facility, or renew an existing certificate, if the agency determines that the facility has satisfied the requirements for certification or recertification. (2) Provisional certificates. (i) A new facility beginning operation after October 1, 1994, is eligible to apply for a provisional certificate. The provisional certificate will enable the facility to perform mammography and to obtain the clinical images needed to complete the accreditation process. To apply for and receive a provisional certificate, a facility must meet the requirements of 42 U.S.C. 263b(c)(4) and submit the necessary information to an approved accreditation body or other entity designated by FDA. (ii) Following the agency's receipt of the accreditation body's decision that a facility has submitted the required information, FDA may issue a provisional certificate to a facility upon determination that the facility has satisfied the requirements of § 900.11(b)(2)(i). A provisional certificate shall be effective for up to 6 months from the date of issuance. A provisional certificate cannot be renewed, but a facility may apply for a 90-day extension of the provisional certificate. (3) Extension of provisiona… | |||
| 21:21:8.0.1.2.36.2.1.3 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | B | Subpart B—Quality Standards and Certification | § 900.12 Quality standards. | FDA | [62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 63 FR 56558, Oct. 22, 1998; 64 FR 18333, Apr. 14, 1999; 64 FR 32408, June 17, 1999; 65 FR 43690, July 14, 2000; 88 FR 15168, Mar. 10, 2023] | (a) Personnel. The following requirements apply to all personnel involved in any aspect of mammography, including the production, processing, and interpretation of mammograms and related quality assurance activities: (1) Interpreting physicians. All physicians interpreting mammograms shall meet the following qualifications: (i) Initial qualifications. Unless the exemption in paragraph (a)(1)(iii)(A) of this section applies, before beginning to interpret mammograms independently, the interpreting physician shall: (A) Be licensed to practice medicine in a State; (B)( 1 ) Be certified in an appropriate specialty area by a body determined by FDA to have procedures and requirements adequate to ensure that physicians certified by the body are competent to interpret radiological procedures, including mammography; or ( 2 ) Have had at least 3 months of documented formal training in the interpretation of mammograms and in topics related to mammography. The training shall include instruction in radiation physics, including radiation physics specific to mammography, radiation effects, and radiation protection. The mammographic interpretation component shall be under the direct supervision of a physician who meets the requirements of paragraph (a)(1) of this section; (C) Have a minimum of 60 hours of documented medical education in mammography, which shall include: Instruction in the interpretation of mammograms and education in basic breast anatomy, pathology, physiology, technical aspects of mammography, and quality assurance and quality control in mammography. All 60 of these hours shall be category I and at least 15 of the category I hours shall have been acquired within the 3 years immediately prior to the date that the physician qualifies as an interpreting physician. Hours spent in residency specifically devoted to mammography will be considered as equivalent to Category I continuing medical education credits and will be accepted if documented in writing by the appropriate representative of the training in… | |||
| 21:21:8.0.1.2.36.2.1.4 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | B | Subpart B—Quality Standards and Certification | § 900.13 Revocation of accreditation and revocation of accreditation body approval. | FDA | (a) FDA action following revocation of accreditation. If a facility's accreditation is revoked by an accreditation body, the agency may conduct an investigation into the reasons for the revocation. Following such investigation, the agency may determine that the facility's certificate shall no longer be in effect or the agency may take whatever other action or combination of actions will best protect the public health, including the establishment and implementation of a corrective plan of action that will permit the certificate to continue in effect while the facility seeks reaccreditation. A facility whose certificate is no longer in effect because it has lost its accreditation may not practice mammography. (b) Withdrawal of FDA approval of an accreditation body. (1) If FDA withdraws approval of an accreditation body under § 900.6, the certificates of facilities previously accredited by such body shall remain in effect for up to 1 year from the date of the withdrawal of approval, unless FDA determines, in order to protect human health or because the accreditation body fraudulently accredited facilities, that the certificates of some or all of the facilities should be revoked or suspended or that a shorter time period should be established for the certificates to remain in effect. (2) After 1 year from the date of withdrawal of approval of an accreditation body, or within any shorter period of time established by the agency, the affected facilities must obtain accreditation from another accreditation body, or from another entity designated by FDA. | ||||
| 21:21:8.0.1.2.36.2.1.5 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | B | Subpart B—Quality Standards and Certification | § 900.14 Suspension or revocation of certificates. | FDA | [62 FR 55976, Oct. 28, 1997. Republished and corrected at 62 FR 60614, Nov. 10, 1997, as amended at 88 FR 15171, Mar. 10, 2023] | (a) Except as provided in paragraph (b) of this section, FDA may suspend or revoke a certificate if FDA finds, after providing the owner or operator of the facility with notice and opportunity for a hearing in accordance with part 16 of this chapter, that the facility, owner, operator, or any employee of the facility: (1) Has been guilty of misrepresentation in obtaining the certificate; (2) Has failed to comply with the standards of § 900.12; (3) Has failed to comply with reasonable requests of FDA, the State certification agency, or the accreditation body for records, information, reports, or materials, including clinical images for an additional mammography review under § 900.12(j), that FDA or the State certification agency believes are necessary to determine the continued eligibility of the facility for a certificate or continued compliance with the standards of § 900.12; (4) Has refused a reasonable request of a duly designated FDA inspector, State inspector, or accreditation body representative for permission to inspect the facility or the operations and pertinent records of the facility; (5) Has violated or aided and abetted in the violation of any provision of or regulation issued pursuant to 42 U.S.C. 263b; (6) Has failed to comply with prior sanctions imposed by FDA or the State certification agency under 42 U.S.C. 263b(h), including a directed plan of correction or a patient and referring physician notification; or (7) Has failed to comply with requests of current or former facility personnel for records of their training or experience relevant to their qualification under MQSA, in violation of § 900.12(a)(4). (b) FDA may suspend the certificate of a facility before holding a hearing if FDA makes a finding described in paragraph (a) of this section and also determines that; (1) The failure to comply with required standards presents a serious risk to human health; (2) The refusal to permit inspection makes immediate suspension necessary; or (3) There is reason to believe that the violation o… | |||
| 21:21:8.0.1.2.36.2.1.6 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | B | Subpart B—Quality Standards and Certification | § 900.15 Appeals of adverse accreditation or reaccreditation decisions that preclude certification or recertification. | FDA | [62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 75 FR 20916, Apr. 22, 2010; 85 FR 18443, Apr. 2, 2020; 88 FR 15171, Mar. 10, 2023] | (a) The appeals procedures described in this section are available only for adverse accreditation or reaccreditation decisions that preclude certification or recertification by FDA. Agency decisions to suspend or revoke certificates that are already in effect will be handled in accordance with § 900.14. (b) Upon learning that a facility has failed to become accredited or reaccredited, FDA will notify the facility that the agency is unable to certify that facility without proof of accreditation. (c) A facility that has been denied accreditation or reaccreditation is entitled to an appeals process from the accreditation body, in accordance with § 900.7. A facility must avail itself of the accreditation body's appeal process before requesting reconsideration from FDA. (d) A facility that cannot achieve satisfactory resolution of an adverse accreditation decision through the accreditation body's appeal process is entitled to further appeal in accordance with procedures set forth in this section and in regulations published in 42 CFR part 498. (1) References to the Centers for Medicare and Medicaid Services in 42 CFR part 498 should be read as the Division of Mammography Quality Standards (DMQS), Center for Devices and Radiological Health, Food and Drug Administration. (2) References to the Appeals Council of the Social Security Administration in 42 CFR part 498 should be read as references to the Departmental Appeals Board. (3) In accordance with the procedures set forth in subpart B of 42 CFR part 498, a facility that has been denied accreditation following appeal to the accreditation body may request reconsideration of that adverse decision from DMQRP. (i) A facility must request reconsideration by DMQS within 60 days of the accreditation body's adverse appeals decision, at the following address: Food and Drug Administration, Center for Devices and Radiological Health, Division of Mammography Quality Standards, Attn: Facility Accreditation Review Committee, 10903 New Hampshire Ave., Bldg. 66, Rm. 3621, Silve… | |||
| 21:21:8.0.1.2.36.2.1.7 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | B | Subpart B—Quality Standards and Certification | § 900.16 Appeals of denials of certification. | FDA | (a) The appeals procedures described in this section are available only to facilities that are denied certification by FDA after they have been accredited by an approved accreditation body. Appeals for facilities that have failed to become accredited are governed by the procedures set forth in § 900.15. (b) FDA may deny the application if the agency has reason to believe that: (1) The facility will not be operated in accordance with standards established under § 900.12; (2) The facility will not permit inspections or provide access to records or information in a timely fashion; or (3) The facility has been guilty of misrepresentation in obtaining the accreditation. (c)(1) If FDA denies an application for certification by a faciity that has received accreditation from an approved accreditation body, FDA shall provide the facility with a statement of the grounds on which the denial is based. (2) A facility that has been denied accreditation may request reconsideration and appeal of FDA's determination in accordance with the applicable provisions of § 900.15(d). | ||||
| 21:21:8.0.1.2.36.2.1.8 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | B | Subpart B—Quality Standards and Certification | § 900.17 [Reserved] | FDA | |||||
| 21:21:8.0.1.2.36.2.1.9 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | B | Subpart B—Quality Standards and Certification | § 900.18 Alternative requirements for § 900.12 quality standards. | FDA | [62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 75 FR 20916, Apr. 22, 2010; 85 FR 18444, Apr. 2, 2020; 88 FR 45067, July 14, 2023] | (a) Criteria for approval of alternative standards. Upon application by a qualified party as defined in paragraph (b) of this section, FDA may approve an alternative to a quality standard under § 900.12, when the agency determines that: (1) The proposed alternative standard will be at least as effective in assuring quality mammography as the standard it proposes to replace, and (2) The proposed alternative: (i) Is too limited in its applicability to justify an amendment to the standard; or (ii) Offers an expected benefit to human health that is so great that the time required for amending the standard would present an unjustifiable risk to the human health; and (3) The granting of the alternative is in keeping with the purposes of 42 U.S.C. 263b. (b) Applicants for alternatives. (1) Mammography facilities and accreditation bodies may apply for alternatives to the quality standards of § 900.12. (2) Federal agencies and State governments that are not accreditation bodies may apply for alternatives to the standards of § 900.12(a). (3) Manufacturers and assemblers of equipment used for mammography may apply for alternatives to the standards of § 900.12(b) and (e). (c) Applications for approval of an alternative standard. An application for approval of an alternative standard or for an amendment or extension of the alternative standard shall be submitted in an original and two copies to the Food and Drug Administration, Center for Devices and Radiological Health, Director, Division of Mammography Quality Standards, 10903 New Hampshire Ave., Bldg. 66, Rm. 3621, Silver Spring, MD 20993-0002. The application for approval of an alternative standard shall include the following information: (1) Identification of the original standard for which the alternative standard is being proposed and an explanation of why the applicant is proposing the alternative; (2) A description of the manner in which the alternative is proposed to deviate from the original standard; (3) A description, supported by data, of the a… | |||
| 21:21:8.0.1.2.36.3.1.1 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | C | Subpart C—States as Certifiers | § 900.20 Scope. | FDA | The regulations set forth in this part implement the Mammography Quality Standards Act (MQSA) (42 U.S.C. 263b). Subpart C of this part establishes procedures whereby a State can apply to become a FDA-approved certification agency to certify facilities within the State to perform mammography services. Subpart C of this part further establishes requirements and standards for State certification agencies to ensure that all mammography facilities under their jurisdiction are adequately and consistently evaluated for compliance with quality standards at least as stringent as the national quality standards established by FDA. | ||||
| 21:21:8.0.1.2.36.3.1.2 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | C | Subpart C—States as Certifiers | § 900.21 Application for approval as a certification agency. | FDA | [62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 75 FR 20916, Apr. 22, 2010; 85 FR 18444, Apr. 2, 2020] | (a) Eligibility. State agencies may apply for approval as a certification agency if they have standards at least as stringent as those of § 900.12, qualified personnel, adequate resources to carry out the States as Certifiers' responsibilities, and the authority to enter into a legal agreement with FDA to accept these responsibilities. (b) Application for approval. (1) An applicant seeking FDA approval as a certification agency shall inform the Food and Drug Administration, Center for Devices and Radiological Health, Director, Division of Mammography Quality Standards, Attn: Program Management Branch, 10903 New Hampshire Ave., Bldg. 66, Rm. 3621, Silver Spring, MD 20993-0002, in writing, of its desire to be approved as a certification agency. (2) Following receipt of the written request, FDA will provide the applicant with additional information to aid in the submission of an application for approval as a certification agency. (3) The applicant shall furnish to FDA, at the address in paragraph (b)(1) of this section, three copies of an application containing the following information, materials, and supporting documentation: (i) Name, address, and phone number of the applicant; (ii) Detailed description of the mammography quality standards the applicant will require facilities to meet and, for those standards different from FDA's quality standards, information substantiating that they are at least as stringent as FDA standards under § 900.12; (iii) Detailed description of the applicant's review and decisionmaking process for facility certification, including: (A) Policies and procedures for notifying facilities of certificate denials and expirations; (B) Procedures for monitoring and enforcement of the correction of deficiencies by facilities; (C) Policies and procedures for suspending or revoking a facility's certification; (D) Policies and procedures that will ensure processing certificates within a timeframe approved by FDA; (E) A description of the appeals process for facilities contesting adve… | |||
| 21:21:8.0.1.2.36.3.1.3 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | C | Subpart C—States as Certifiers | § 900.22 Standards for certification agencies. | FDA | The certification agency shall accept the following responsibilities in order to ensure quality mammography at the facilities it certifies and shall perform these responsibilities in a manner that ensures the integrity and impartiality of the certification agency's actions: (a) Conflict of interest. The certification agency shall establish and implement measures that FDA has approved in accordance with § 900.21(b) to reduce the possibility of conflict of interest or facility bias on the part of individuals acting on the certification agency's behalf. (b) Certification and inspection responsibilities. Mammography facilities shall be certified and inspected in accordance with statutory and regulatory requirements that are at least as stringent as those of MQSA and this part. (c) Compliance with quality standards. The scope, timeliness, disposition, and technical accuracy of completed inspections and related enforcement activities shall ensure compliance with facility quality standards required under § 900.12. (d) Enforcement actions. (1) There shall be appropriate criteria and processes for the suspension and revocation of certificates. (2) There shall be prompt investigation of and appropriate enforcement action for facilities performing mammography without certificates. (e) Appeals. There shall be processes for facilities to appeal inspection findings, enforcement actions, and adverse certification decision or adverse accreditation decisions after exhausting appeals to the accreditation body. (f) Additional mammography review. There shall be a process for the certification agency to request additional mammography review from accreditation bodies for issues related to mammography image quality and clinical practice. The certification agency should request additional mammography review only when it believes that mammography quality at a facility has been compromised and may present a serious risk to human health. (g) Patient notification. There shall be processes for the certification agency t… | ||||
| 21:21:8.0.1.2.36.3.1.4 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | C | Subpart C—States as Certifiers | § 900.23 Evaluation. | FDA | FDA shall evaluate annually the performance of each certification agency. The evaluation shall include the use of performance indicators that address the adequacy of program performance in certification, inspection, and enforcement activities. FDA will also consider any additional information deemed relevant by FDA that has been provided by the certification body or other sources or has been required by FDA as part of its oversight mandate. The evaluation also shall include a review of any changes in the standards or procedures in the areas listed in §§ 900.21(b) and 900.22 that have taken place since the original application or the last evaluation, whichever is most recent. The evaluation shall include a determination of whether there are major deficiencies in the certification agency's regulations or performance that, if not corrected, would warrant withdrawal of the approval of the certification agency under the provisions of § 900.24, or minor deficiencies that would require corrective action. | ||||
| 21:21:8.0.1.2.36.3.1.5 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | C | Subpart C—States as Certifiers | § 900.24 Withdrawal of approval. | FDA | If FDA determines, through the evaluation activities of § 900.23, or through other means, that a certification agency is not in substantial compliance with this subpart, FDA may initiate the following actions: (a) Major deficiencies. If, after providing notice and opportunity for corrective action, FDA determines that a certification agency has demonstrated willful disregard for public health, has committed fraud, has failed to provide adequate resources for the program, has submitted material false statements to the agency, has failed to achieve the MQSA goals of quality mammography and access, or has performed or failed to perform a delegated function in a manner that may cause serious risk to human health, FDA may withdraw its approval of that certification agency. The certification agency shall notify, within a time period and in a manner approved by FDA, all facilities certified or seeking certification by it that it has been required to correct major deficiencies. (1) FDA shall notify the certification agency of FDA's action and the grounds on which the approval was withdrawn. (2) A certification agency that has lost its approval shall notify facilities certified or seeking certification by it, as well as the appropriate accreditation bodies with jurisdiction in the State, that its approval has been withdrawn. Such notification shall be made within a timeframe and in a manner approved by FDA. (b) Minor deficiencies. If FDA determines that a certification agency has demonstrated deficiencies in performing certification functions and responsibilities that are less serious or more limited than the deficiencies in paragraph (a) of this section, including failure to follow the certification agency's own procedures and policies as approved by FDA, FDA shall notify the certification agency that it has a specified period of time to take particular corrective measures as directed by FDA or to submit to FDA for approval the certification agency's own plan of corrective action addressing the minor deficiencies… | ||||
| 21:21:8.0.1.2.36.3.1.6 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | C | Subpart C—States as Certifiers | § 900.25 Hearings and appeals. | FDA | (a) Opportunities to challenge final adverse actions taken by FDA regarding approval of certification agencies or withdrawal of approval of certification agencies shall be communicated through notices of opportunity for informal hearings in accordance with part 16 of this chapter. (b) A facility that has been denied certification is entitled to an appeals process from the certification agency. The appeals process shall be specified in writing by the certification agency and shall have been approved by FDA in accordance with §§ 900.21 and 900.22. |
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