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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 April 1 2020.

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]
[Revised as of April 1, 2020]
[CITE: 21CFR1003.20]
See Related Information on Notification by the manufacturer to the Secretary. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER J - RADIOLOGICAL HEALTH

PART 1003 -- NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY

Subpart C - Notification

Sec. 1003.20 Notification by the manufacturer to the Secretary.

The notification to the Secretary required by § 1003.10(a) shall be confirmed in writing and, in addition to other relevant information which the Secretary may require, shall include the following:

(a) Identification of the product or products involved;

(b) The total number of such product units so produced, and the approximate number of such product units which have left the place of manufacture;

(c) The expected usage for the product if known to the manufacturer;

(d) A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard;

(e) An evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard;

(f) A statement of the measures to be taken to repair such defect or to bring the product into compliance with the Federal standard;

(g) The date and circumstances under which the defect was discovered; and

(h) The identification of any trade secret information which the manufacturer desires kept confidential.

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