![]() |
Code of Federal Regulations (Last Updated: July 5, 2024) |
![]() |
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 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. |