Title 21, Part 830 — Unique Device Identification
20 sections
Section 830.3
Definitions.
Section 830.10
Incorporation by reference.
Section 830.20
Requirements for a unique device identifier.
Section 830.40
Use and discontinuation of a device identifier.
Section 830.50
Changes that require use of a new device identifier.
Section 830.60
Relabeling of a device that is required to bear a unique device identifier.
Section 830.100
FDA accreditation of an issuing agency.
Section 830.110
Application for accreditation as an issuing agency.
Section 830.120
Responsibilities of an FDA-accredited issuing agency.
Section 830.130
Suspension or revocation of the accreditation of an issuing agency.
Section 830.200
When FDA will act as an issuing agency.
Section 830.210
Eligibility for use of FDA as an issuing agency.
Section 830.220
Termination of FDA service as an issuing agency.
Section 830.300
Devices subject to device identification data submission requirements.
Section 830.310
Information required for unique device identification.
Section 830.320
Submission of unique device identification information.
Section 830.330
Times for submission of unique device identification information.
Section 830.340
Voluntary submission of ancillary device identification information.
Section 830.350
Correction of information submitted to the Global Unique Device Identification Database.
Section 830.360
Records to be maintained by the labeler.