[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR900.3]

[Page 557-559]
 
                        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 A_Accreditation
 
Sec. 900.3  Application for approval as an accreditation body.

    (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 and Radiation Programs (DMQRP), Center for 
Devices and Radiology Health (HFZ-240), Food and Drug Administration, 
1350 Piccard Dr., Rockville, MD 20850, marked Attn: Mammography 
Standards 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 Sec. 
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 Sec. 
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 Sec. 900.4(c), random clinical 
image reviews in accordance with Sec. 900.4(f), and

[[Page 558]]

additional mammography review in accordance with Sec. 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 application forms, guidelines, 
instructions, and other materials the applicant will send to facilities 
during the accreditation process, including an accreditation history 
form that requires each facility to provide a complete history of prior 
accreditation activities and a statement that all information and data 
submitted in the application is true and accurate, and that no material 
fact has been omitted;
    (G) Policies and procedures for notifying facilities of 
deficiencies;
    (H) Procedures for monitoring corrections of deficiencies by 
facilities;
    (I) Policies and procedures for suspending or revoking a facility's 
accreditation;
    (J) Policies and procedures that will ensure processing of 
accreditation applications and renewals within a timeframe approved by 
FDA and assurances that the body will adhere to such policies and 
procedures; and
    (K) A description of the applicant's appeals process for facilities 
contesting adverse accreditation status decisions.
    (iv) Education, experience, and training requirements for the 
applicant's professional staff, including reviewers of clinical or 
phantom images;
    (v) Description of the applicant's electronic data management and 
analysis system with respect to accreditation review and decision 
processes and the applicant's ability to provide electronic data in a 
format compatible with FDA data systems;
    (vi) Resource analysis that demonstrates that the applicant's 
staffing, funding, and other resources are adequate to perform the 
required accreditation activities;
    (vii) Fee schedules with supporting cost data;
    (viii) Statement of policies and procedures established to avoid 
conflicts of interest or the appearance of conflicts of interest by the 
applicant's board members, commissioners, professional personnel 
(including reviewers of clinical and phantom images), consultants, 
administrative personnel, and other representatives of the applicant;
    (ix) Statement of policies and procedures established to protect 
confidential information the applicant will collect or receive in its 
role as an accreditation body;
    (x) Disclosure of any specific brand of imaging system or component, 
measuring device, software package, or other commercial product used in 
mammography that the applicant develops, sells, or distributes;
    (xi) Description of the applicant's consumer complaint mechanism;
    (xii) Satisfactory assurances that the applicant shall comply with 
the requirements of Sec. 900.4; and
    (xiii) Any other information as may be required by FDA.
    (c) Application for renewal of approval. An approved accreditation 
body that intends to continue to serve as an accreditation body beyond 
its current term shall apply to FDA for renewal or notify FDA of its 
plans not to apply for renewal in accordance with the following 
procedures and schedule:
    (1) At least 9 months before the date of expiration of a body's 
approval, the body shall inform FDA, at the address given in Sec. 
900.3(b)(1), of its intent to seek renewal.
    (2) FDA will notify the applicant of the relevant information, 
materials, and supporting documentation required under Sec. 900.3(b)(3) 
that the applicant shall submit as part of the renewal procedure.
    (3) At least 6 months before the date of expiration of a body's 
approval, the applicant shall furnish to FDA, at the address in Sec. 
900.3(b)(1), three copies of a renewal application containing the 
information, materials, and supporting documentation requested by FDA in 
accordance with Sec. 900.3(c)(2).
    (4) No later than July 28, 1998, any accreditation body approved 
under the interim regulations published in the Federal Register of 
December 21, 1993 (58 FR 67558), that desires to continue to serve as an 
accreditation body under

[[Page 559]]

the final regulations shall apply for renewal of approval in accordance 
with the procedures set forth in paragraphs (c)(1) through (c)(3) of 
this section.
    (5) Any accreditation body that does not plan to renew its approval 
shall so notify FDA at the address given in paragraph (b)(1) of this 
section at least 9 months before the expiration of the body's term of 
approval.
    (d) Rulings on applications for initial and renewed 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 accreditation standards the applicant will 
require facilities to meet are substantially the same as the quality 
standards published under subpart B of this part.
    (2) FDA will notify the applicant of any deficiencies in the 
application and request that those deficiencies be rectified within a 
specified time period. If the deficiencies are not rectified to FDA's 
satisfaction within the specified time period, the application for 
approval as an accreditation body may be rejected.
    (3) FDA shall notify the applicant whether the application has been 
approved or denied. That 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.
    (6) If FDA does not reach a final decision on a renewal application 
in accordance with this paragraph before the expiration of an 
accreditation body's current term of approval, the approval will be 
deemed extended until the agency reaches a final decision on the 
application, unless an accreditation body does not rectify deficiencies 
in the application within the specified time period, as required in 
paragraph (d)(2) of this section.
    (e) Relinquishment of authority. An accreditation body that decides 
to relinquish its accreditation authority before expiration of the 
body's term of approval shall submit a letter of such intent to FDA, at 
the address in Sec. 900.3(b)(1), at least 9 months before relinquishing 
such authority.
    (f) Transfer of records. An accreditation body that does not apply 
for renewal of accreditation body approval, is denied such approval by 
FDA, or relinquishes its accreditation authority and duties before 
expiration of its term of approval, shall:
    (1) Transfer facility records and other related information as 
required by FDA to a location and according to a schedule approved by 
FDA.
    (2) Notify, in a manner and time period approved by FDA, all 
facilities accredited or seeking accreditation by the body that the body 
will no longer have accreditation authority.
    (g) Scope of authority. An accreditation body's term of approval is 
for a period not to exceed 7 years. FDA may limit the scope of 
accreditation authority.

[62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997]