[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR900.21]

[Page 564-565]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 900--MAMMOGRAPHY--Table of Contents
 
                     Subpart C--States as Certifiers
 
Sec. 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 Sec. 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 (HFZ-240), Food and Drug Administration, Rockville, 
MD 20850, marked Attn: SAC\1\ Coordinator, in writing, of its desire to 
be approved as a certification agency.
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    \1\SAC means States as Certifiers.
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    (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 Sec. 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 
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;

[[Page 565]]

    (L) Policies and procedures for monitoring and enforcing the 
correction of facility deficiencies discovered during inspections or by 
other means;
    (M) Policies and procedures for additional mammography review and 
for requesting such reviews from accreditation bodies;
    (N) Policies and procedures for patient notification;
    (O) If a State has regulations that are more stringent than those of 
Sec. 900.12, an explanation of how adverse actions taken against a 
facility under the more stringent regulations will be distinguished from 
those taken under the requirements of Sec. 900.12; and
    (P) Any other information that FDA identifies as necessary to make a 
determination on the approval of the State as a certification agency.
    (c) Rulings on applications for approval. (1) FDA will conduct a 
review and evaluation to determine whether the applicant substantially 
meets the applicable requirements of this subpart and whether the 
certification standards the applicant will require facilities to meet 
are the quality standards published under subpart B of this part or at 
least as stringent as those of subpart B.
    (2) FDA will notify the applicant of any deficiencies in the 
application and request that those deficiencies be corrected within a 
specified time period. If the deficiencies are not corrected to FDA's 
satisfaction within the specified time period, FDA may deny the 
application for approval as a certification agency.
    (3) FDA shall notify the applicant whether the application has been 
approved or denied. The notification shall list any conditions 
associated with approval or state the bases for any denial.
    (4) The review of any application may include a meeting between FDA 
and representatives of the applicant at a time and location mutually 
acceptable to FDA and the applicant.
    (5) FDA will advise the applicant of the circumstances under which a 
denied application may be resubmitted.
    (d) Scope of authority. FDA may limit the scope of certification 
authority delegated to the State in accordance with MQSA.