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become effective on the date specified in the written notice of the action sent to the applicant, except that it will become effective immediately upon notification of the applicant when FDA determines that such action is necessary to prevent an imminent health hazard. [62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997]
Subpart C-States as Certifiers
SOURCE: 67 FR 5467, Feb. 6, 2002, unless otherwise noted.
$ 900.20 Scope.
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 the national quality standards established by FDA.
(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 (bXl of this section, three copies of an application containing the following infor mation, materials, and supporting doc umentation:
(i) Name, address, and phone number of the applicant;
(ii) Detailed description of the mam. mography 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 a stringent FDA standards under $ 900.12;
(iii) Detailed description of the applicant's review and decisionmaking pros ess for facility certification, includingi
(A) Policies and procedures for not fying facilities of certificate denials and expirations;
(B) Procedures for monitoring and enforcement of the correction of deficiencies by facilities;
(C) Policies and procedures for sus. pending 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 adverse certification status decisions;
(F) Education, experience, and training requirements of the applicant's professional and supervisory staff;
(G) Description of the applicant's electronic data management and analysis system;
(H) Fee schedules;
(I) Statement of policies and procedures established to avoid conflict of interest;
(J) Description of the applicant's mechanism for handling facility inquiries and complaints;
(K) Description of a plan to ensure that certified mammography facilities will be inspected according to MQSA (42 U.S.C. 263b) and procedures and policies for notifying facilities of inspection deficiencies;
$ 900.21 Application for approval as a
certification agency. (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 Division of Mammography Quality and Radiation Programs (DMQRP), Center for Devices and Radiological Health (HFZ240), Food and Drug Administration, Rockville, MD 20850, marked Attn: SAC Coordinator, in writing, of its desire to be approved as a certification agency.
ISAC means States as Certifiers.
Policies and procedures for moni- $ 900.22 Standards for certification ig and enforcing the correction of agencies. ity deficiencies discovered during
The certification agency shall accept actions or by other means;
the following responsibilities in order ) Policies and procedures for addi
to ensure quality mammography at the al mammography review and for
facilities it certifies and shall perform esting such reviews from accredi
these responsibilities in a manner that on bodies;
ensures the integrity and impartiality ) Policies and procedures for pa
of the certification agency's actions: t notification;
(a) Conflict of interest. The certifi) If a State has regulations that
cation agency shall establish and immore stringent than those of
plement measures that FDA has ap.12, an explanation of how adverse
proved in accordance with $900.21(b) to ons taken against a facility under
reduce the possibility of conflict of inmore stringent regulations will be terest or facility bias on the part of ininguished from those taken under dividuals acting on the certification requirements of 8 900.12; and
agency's behalf. ) Any other information that FDA
(b) Certification and inspection respontifies as necessary to make a de- sibilities. Mammography facilities shall nination on the approval of the be certified and inspected in accordte as a certification agency.
ance with statutory and regulatory re) Rulings on applications for ap- quirements that are at least as strinal. (1) FDA will conduct a review gent as those of MQSA and this part.
evaluation to determine whether (c) Compliance with quality standards. applicant substantially meets the The scope, timeliness, disposition, and licable requirements of this subpart technical accuracy of completed in
whether the certification stand- spections and related enforcement acs the applicant will require facili- tivities shall ensure compliance with
to meet are the quality standards facility quality standards required lished under subpart B of this part under $900.12. at least as stringent as those of sub- (d) Enforcement actions. (1) There t B.
shall be appropriate criteria and proc2) FDA will notify the applicant of esses for the suspension and revocation i deficiencies in the application and of certificates. uest that those deficiencies be cor- (2) There shall be prompt investigated within a specified time period. If tion of and appropriate enforcement . deficiencies are not corrected to action for facilities performing mamA's satisfaction within the specified mography without certificates. ne period, FDA may deny the appli- (e) Appeals. There shall be processes tion for approval as a certification for facilities to appeal inspection findency.
ings, enforcement actions, and adverse 3) FDA shall notify the applicant certification decision or adverse aclether the application has been ap- creditation decisions after exhausting oved or denied. The notification shall appeals to the accreditation body. it any conditions associated with ap- (f) Additional mammography review. oval or state the bases for any de- There shall be a process for the certifial.
cation agency to request additional (4) The review of any application may mammography review from accreditaclude a meeting between FDA and tion bodies for issues related to mampresentatives of the applicant at a mography image quality and clinical me and location mutually acceptable practice. The certification
agency ) FDA and the applicant.
should request additional mammog(5) FDA will advise the applicant of raphy review only when it believes that ne circumstances under which a de- mammography quality at a facility has ied application may be resubmitted. been compromised and may present a (d) Scope of authority. FDA may limit serious risk to human health. he scope of certification authority (g) Patient notification. There shall be elegated to the State in accordance processes for the certification agency
to conduct, or cause to be conducted,
patient notifications should the certification agency determine that mammography quality has been compromised to such an extent that it may present a serious risk to human health.
(h) Electronic data transmission. There shall be processes to ensure the timeliness and accuracy of electronic transmission of inspection data and facility certification status information in a format and timeframe determined by FDA.
(i) Changes to standards. A certification agency shall obtain FDA authorization for any changes it proposes to make in any standard that FDA has previously accepted under $900.21 before requiring facilities to comply with the changes as a condition of obtaining or maintaining certification.
$ 900.23 Evaluation.
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 88 900.21(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. $ 900.24 Withdrawal of approval.
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 cor
rective 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 per forming certification functions and responsibilities that are less serious of more limited than the deficiencies in paragraph (a) of this section, including failure to follow the certification agency's own procedures and policies as ap proved by FDA, FDA shall notify the certification agency that it has a spec: fied 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. If the approved corrective actions are not being implemented satisfactorily or within the established schedule, FDA may place the agency on probationary status for a period of time determined by FDA, or may withdraw approval of the certification agency.
(1) If FDA places a certification agency on probationary status, the certification agency shall notify all facilities
timeframe and in a manner approved by FDA.
(c) Transfer of records. A certification agency that has its approval withdrawn shall transfer facility records and other related information as required by FDA to a location and according to a schedule approved by FDA.
?rtified or seeking certification by it its probationary status within a me period and in a manner approved 7 FDA. (2) Probationary status shall remain
effect until such time as the certifiition agency can demonstrate to the tisfaction of FDA that it has successlly implemented or is implementing le corrective action plan within the tablished schedule, and that the corictive actions have substantially iminated all identified problems, or (3) If FDA determines that a certifiition agency that has been placed on robationary status is not implelenting corrective actions satisfacrily or within the established schedle, FDA may withdraw approval of the ertification agency. The certification gency shall notify all facilities cerfied or seeking certification by it, as ell as the appropriate accreditation odies with jurisdiction in the State, of s loss of FDA approval, within a
8 900.25 Hearings and appeals.
(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.
SUBCHAPTER J-RADIOLOGICAL HEALTH
(c) Chassis family means a group of one or more models with all of the following common characteristics:
(1) The same circuitry in the high voltage, horizontal oscillator, and power supply sections;
(2) The same worst component failures;
(3) The same type of high voltage hold-down or safety circuits; and
(4) The same design and installation, (d) Commerce means:
(1) Commerce between any place in any State and any place outside thereof, and
(2) Commerce wholly within the District of Columbia.
(e) Component, for the purposes of this part, means an essential functional part of a subassembly or of an assembled electronic product, and which may affect the quantity, quality, direction, or radiation emission of the finished product.
(f) Dealer means a person engaged in the business of offering electronic products for sale to purchasers, without regard to whether such person is or has been primarily engaged in such business, and includes persons who offer such products for lease or as prizes or awards.
(g) Director means the Director of the Center for Devices and Radiological Health.
(h) Distributor means a person engaged in the business of offering elettronic products for sale to dealers, without regard to whether such person is or has been primarily or customarily engaged in such business.
(i) Electromagnetic radiation includes the entire electromagnetic spectrum of radiation of any wavelength. The electromagnetic spectrum illustrated in figure 1 includes, but is not limited to, gamma rays, x-rays, ultra-violet, visible, infrared, microwave, radiowave, and low frequency radiation.
Subpart A-General Provisions
$ 1000.1 General.
References in this subchapter J to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.
(50 FR 33688, Aug. 20, 1985)
$ 1000.3 Definitions.
As used in this subchapter J:
(a) Accidental radiation occurrence means a single event or series of events that has have resulted in injurious or potentially injurious exposure of any person to electronic product radiation as a result of the manufacturing, testing, or use of an electronic product.
(b) Act means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360hh-360ss).