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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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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES
 
PART 830UNIQUE DEVICE IDENTIFICATION
 

Subpart A - General Provisions
   § 830.3 - Definitions.

Subpart B - Requirements for a Unique Device Identifier
   § 830.10 - Incorporation by reference.
   § 830.20 - Requirements for a unique device identifier.
   § 830.40 - Use and discontinuation of a device identifier.
   § 830.50 - Changes that require use of a new device identifier.
   § 830.60 - Relabeling of a device that is required to bear a unique device identifier.

Subpart C - FDA Accreditation of an Issuing Agency
   § 830.100 - FDA accreditation of an issuing agency.
   § 830.110 - Application for accreditation as an issuing agency.
   § 830.120 - Responsibilities of an FDA-accredited issuing agency.
   § 830.130 - Suspension or revocation of the accreditation of an issuing agency.

Subpart D - FDA as an Issuing Agency
   § 830.200 - When FDA will act as an issuing agency.
   § 830.210 - Eligibility for use of FDA as an issuing agency.
   § 830.220 - Termination of FDA service as an issuing agency.

Subpart E - Global Unique Device Identification Database
   § 830.300 - Devices subject to device identification data submission requirements.
   § 830.310 - Information required for unique device identification.
   § 830.320 - Submission of unique device identification information.
   § 830.330 - Times for submission of unique device identification information.
   § 830.340 - Voluntary submission of ancillary device identification information.
   § 830.350 - Correction of information submitted to the Global Unique Device Identification Database.
   § 830.360 - Records to be maintained by the labeler.

Authority: 21 U.S.C. 321, 331, 352, 353, 360, 360d, 360i, 360j, 371.
Source: 78 FR 58823, Sept. 24, 2013, unless otherwise noted.

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