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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: 21CFR830.210]
 See Related Information on Eligibility for use of FDA as an issuing agency. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

PART 830 -- UNIQUE DEVICE IDENTIFICATION

Subpart D - FDA as an Issuing Agency

Sec. 830.210 Eligibility for use of FDA as an issuing agency.

When FDA acts as an issuing agency, any labeler will be permitted to use FDA's unique device identification system, regardless of whether the labeler is considered a small business.

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