CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR900.7]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER I - MAMMOGRAPHY QUALITY STANDARDS ACT

PART 900 -- MAMMOGRAPHY

Subpart A - Accreditation

Sec. 900.7 Hearings.

(a) Opportunities to challenge final adverse actions taken by FDA regarding approval or reapproval of accreditation bodies, withdrawal of approval of accreditation bodies, or rejection of a proposed fee for accreditation 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 accreditation is entitled to an appeals process from the accreditation body. The appeals process shall be specified in writing by the accreditation body and shall have been approved by FDA in accordance with § 900.3(d) or § 900.4(a)(8).

(c) A facility that cannot achieve satisfactory resolution of an adverse accreditation decision through the accreditation body's appeals process may appeal to FDA for reconsideration in accordance with § 900.15.