FDA 21 CFR Part 830 Unique Device Identification

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FDA 21 CFR Part 830 Unique Device Identification

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Table of contents

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.



FDA 21 CFR Part 830 Unique Device Identification:

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