Part 830 — Unique Device Identification
Current through Sep 8, 2026
Authority: 21 U.S.C. 321, 331, 352, 353, 360, 360d, 360i, 360j, 371.
Source: 78 FR 58823, Sept. 24, 2013, unless otherwise noted.
Sections
- § 830.3 Definitions.
- § 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.
- § 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.
- § 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.
- § 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.