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Title 21 Part 830

Title 21 → Chapter I → Subchapter H → Part 830

Electronic Code of Federal Regulations e-CFR

Title 21 Part 830

Title 21Chapter ISubchapter HPart 830


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER H—MEDICAL DEVICES

PART 830—UNIQUE DEVICE IDENTIFICATION

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Subpart A—GENERAL PROVISIONS

§830.3
Definitions.
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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.
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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.
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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.
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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.