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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR1003.30]
See Related Information on Application for exemption from notification requirements. 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 D--Exemptions From Notification Requirements

Sec. 1003.30 Application for exemption from notification requirements.

(a) A manufacturer may at the time of giving the written confirmation required by 1003.20 or within 15 days of the receipt of any notice from the Secretary pursuant to 1003.11(a), apply for an exemption from the requirement of notice to the persons specified in 1003.10(b).

(b) The application for exemption shall contain the information required by 1003.20 and in addition shall set forth in detail the grounds upon which the exemption is sought.

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