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Title 21

Displaying title 21, up to date as of 9/20/2021. Title 21 was last amended 9/17/2021.
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Title 21 Food and Drugs Part / Section
Chapter I Food and Drug Administration, Department of Health and Human Services 1 – 1299
Subchapter H Medical Devices 800 – 898
Part 830 Unique Device Identification 830.3 – 830.360
Subpart A General Provisions 830.3
§ 830.3 Definitions.
Subpart B Requirements for a Unique Device Identifier 830.10 – 830.60
§ 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 – 830.130
§ 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 – 830.220
§ 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 – 830.360
§ 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.