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