21 CFR Part 830
PART 830—UNIQUE DEVICE IDENTIFICATION
- PART 830—UNIQUE DEVICE IDENTIFICATION
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter H—Medical Devices
- 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.
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