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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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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).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[CITE: 21CFR900.13]
See Related Information on Revocation of accreditation and revocation of accreditation body approval. in CDRH databases



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 B - Quality Standards and Certification

Sec. 900.13 Revocation of accreditation and revocation of accreditation body approval.

(a) FDA action following revocation of accreditation. If a facility's accreditation is revoked by an accreditation body, the agency may conduct an investigation into the reasons for the revocation. Following such investigation, the agency may determine that the facility's certificate shall no longer be in effect or the agency may take whatever other action or combination of actions will best protect the public health, including the establishment and implementation of a corrective plan of action that will permit the certificate to continue in effect while the facility seeks reaccreditation. A facility whose certificate is no longer in effect because it has lost its accreditation may not practice mammography.

(b) Withdrawal of FDA approval of an accreditation body. (1) If FDA withdraws approval of an accreditation body under § 900.6, the certificates of facilities previously accredited by such body shall remain in effect for up to 1 year from the date of the withdrawal of approval, unless FDA determines, in order to protect human health or because the accreditation body fraudulently accredited facilities, that the certificates of some or all of the facilities should be revoked or suspended or that a shorter time period should be established for the certificates to remain in effect.

(2) After 1 year from the date of withdrawal of approval of an accreditation body, or within any shorter period of time established by the agency, the affected facilities must obtain accreditation from another accreditation body, or from another entity designated by FDA.

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