[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: 21CFR900.18]

[Page 553-555]
 
                        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. 900.18  Alternative requirements for Sec. 900.12 quality standards.

    (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 Sec. 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:

[[Page 554]]

    (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 Sec. 900.12.
    (2) Federal agencies and State governments that are not 
accreditation bodies may apply for alternatives to the standards of 
Sec. 900.12(a).
    (3) Manufacturers and assemblers of equipment used for mammography 
may apply for alternatives to the standards of Sec. 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 Director, Division of Mammography Quality 
and Radiation Programs (HFZ-240), Center for Devices and Radiological 
Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 
20850. 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 advantages to be 
derived from such deviation;
    (4) An explanation, supported by data, of how such a deviation would 
ensure equal or greater quality of production, processing, or 
interpretation of mammograms than the original standard;
    (5) The suggested period of time that the proposed alternative 
standard would be in effect; and
    (6) Such other information required by the Director to evaluate and 
act on the application.
    (d) Ruling on applications. (1) FDA may approve or deny, in whole or 
in part, a request for approval of an alternative standard or any 
amendment or extension thereof, and shall inform the applicant in 
writing of this action. The written notice shall state the manner in 
which the requested alternative standard differs from the agency 
standard and a summary of the reasons for approval or denial of the 
request. If the request is approved, the written notice shall also 
include the effective date and the termination date of the approval and 
a summary of the limitations and conditions attached to the approval and 
any other information that may be relevant to the approved request. Each 
approved alternative standard shall be assigned an identifying number.
    (2) Notice of an approved request for an alternative standard or any 
amendment or extension thereof shall be placed in the public docket file 
in the Dockets Management Branch and may also be in the form of a notice 
published in the Federal Register. The notice shall state the name of 
the applicant, a description of the published agency standard, and a 
description of the approved alternative standard, including limitations 
and conditions attached to the approval of the alternative standard.
    (3) Summaries of the approval of alternative standards, including 
information on their nature and number, shall be provided to the 
National Mammography Quality Assurance Advisory Committee.
    (4) All applications for approval of alternative standards and for 
amendments and extensions thereof and all correspondence (including 
written notices of approval) on these applications shall be available 
for public disclosure in the Dockets Management Branch, excluding 
patient identifiers and confidential commercial information.
    (e) Amendment or extension of an alternative standard. An 
application for amending or extending approval of an alternative 
standard shall include the following information:

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    (1) The approval number and the expiration date of the alternative 
standard;
    (2) The amendment or extension requested and the basis for the 
amendment or extension; and
    (3) An explanation, supported by data, of how such an amendment or 
extension would ensure equal or greater quality of production, 
processing, or interpretation of mammograms than the original standard.
    (f) Applicability of the alternative standards. (1) Except as 
provided in paragraphs (f)(2) and (f)(3) of this section, any approval 
of an alternative standard, amendment, or extension may be implemented 
only by the entity to which it was granted and under the terms under 
which it was granted. Other entities interested in similar or identical 
approvals must file their own application following the procedures of 
paragraph (c) of this section.
    (2) When an alternative standard is approved for a manufacturer of 
equipment, any facility using that equipment will also be covered by the 
alternative standard.
    (3) The agency may extend the alternative standard to other entities 
when FDA determines that expansion of the approval of the alternative 
standard would be an effective means of promoting the acceptance of 
measures to improve the quality of mammography. All such determinations 
will be publicized by appropriate means.
    (g) Withdrawal of approval of alternative requirements. FDA shall 
amend or withdraw approval of an alternative standard whenever the 
agency determines that this action is necessary to protect the human 
health or otherwise is justified by Sec. 900.12. Such action will 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]