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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: 21CFR1005.21]
See Related Information on Application for permission to bring product into compliance. 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 1005 -- IMPORTATION OF ELECTRONIC PRODUCTS

Subpart C--Bonding and Compliance Procedures

Sec. 1005.21 Application for permission to bring product into compliance.

Application for permission to perform such action as is necessary to bring the product into compliance with the Act may be filed only by the owner, consignee, or manufacturer and, in addition to any other information which the Secretary may reasonably require, shall:

(a) Contain a detailed proposal for bringing the product into compliance with the Act;

(b) Specify the time and place where such operations will be effected and the approximate time for their completion; and

(c) Identify the bond required to be filed pursuant to 1005.23.

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