[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR900.11]

[Page 537-538]
 
                        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 B--Quality Standards and Certification
 
Sec. 900.11  Requirements for certification.

    (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 Sec. 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)(2) 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 Sec. 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 provisional certificate. (i) To apply for a 90-day 
extension to a provisional certificate, a facility shall submit to its 
accreditation body, or other entity designated by FDA, a statement of 
what the facility is doing to obtain certification and evidence that 
there would be a significant adverse impact on access to mammography in 
the geographic area served if such facility did not obtain an extension.
    (ii) The accreditation body shall forward the request, with its 
recommendation, to FDA within 2 business days after receipt.
    (iii) FDA may issue a 90-day extension for a provisional certificate 
upon determination that the extension meets the criteria set forth in 42 
U.S.C. 263b(c)(2).
    (iv) There can be no renewal of a provisional certificate beyond the 
90-day extension.
    (c) Reinstatement policy. A previously certified facility that has 
allowed its certificate to expire, that has been refused a renewal of 
its certificate by FDA, or that has had its certificate suspended or 
revoked by FDA, may apply to have the certificate reinstated so that the 
facility may be considered to be a new facility and thereby be eligible 
for a provisional certificate.
    (1) Unless prohibited from reinstatement under Sec. 900.11(c)(4), a 
facility applying for reinstatement shall:
    (i) Contact an FDA-approved accreditation body or other entity 
designated by FDA to determine the requirements for reapplication for 
accreditation;
    (ii) Fully document its history as a previously provisionally 
certified or certified mammography facility, including the following 
information:
    (A) Name and address of the facility under which it was previously 
provisionally certified or certified;

[[Page 538]]

    (B) Name of previous owner/lessor;
    (C) FDA facility identification number assigned to the facility 
under its previous certification; and
    (D) Expiration date of the most recent FDA provisional certificate 
or certificate; and
    (iii) Justify application for reinstatement of accreditation by 
submitting to the accreditation body or other entity designated by FDA, 
a corrective action plan that details how the facility has corrected 
deficiencies that contributed to the lapse of, denial of renewal, or 
revocation of its certificate.
    (2) FDA may issue a provisional certificate to the facility if:
    (i) The accreditation body or other entity designated by FDA 
notifies the agency that the facility has adequately corrected, or is in 
the process of correcting, pertinent deficiencies; and
    (ii) FDA determines that the facility has taken sufficient 
corrective action since the lapse of, denial of renewal, or revocation 
of its previous certificate.
    (3) After receiving the provisional certificate, the facility may 
lawfully resume performing mammography services while completing the 
requirements for certification.
    (4) If a facility's certificate was revoked on the basis of an act 
described in 41 U.S.C. 263b(i)(1), no person who owned or operated that 
facility at the time the act occurred may own or operate a mammography 
facility within 2 years of the date of revocation.