21 CFR
Part 830 Unique Device Identification
Subpart A - General Provisions
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 112 × 483
- § 830.310 Information required for unique device identification 25 × 483
- § 830.320 Submission of unique device identification information 2 × 483
- § 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