Title 21

PART 830

Part 830 - Unique Device Identification

PART 830 - UNIQUE DEVICE IDENTIFICATION Authority:21 U.S.C. 321, 331, 352, 353, 360, 360d, 360i, 360j, 371. Source:78 FR 58823, Sept. 24, 2013, unless otherwise noted.

• Authority: 21 U.S.C. 321, 331, 352, 353, 360, 360d, 360i, 360j, 371.
• Source: 78 FR 58823, Sept. 24, 2013, unless otherwise noted.

21:8.0.1.1.15.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.15.1.1.1	SECTION 830.3	830.3 Definitions.
21:8.0.1.1.15.2	SUBPART B	Subpart B - Requirements for a Unique Device Identifier
21:8.0.1.1.15.2.1.1	SECTION 830.10	830.10 Incorporation by reference.
21:8.0.1.1.15.2.1.2	SECTION 830.20	830.20 Requirements for a unique device identifier.
21:8.0.1.1.15.2.1.3	SECTION 830.40	830.40 Use and discontinuation of a device identifier.
21:8.0.1.1.15.2.1.4	SECTION 830.50	830.50 Changes that require use of a new device identifier.
21:8.0.1.1.15.2.1.5	SECTION 830.60	830.60 Relabeling of a device that is required to bear a unique device identifier.
21:8.0.1.1.15.3	SUBPART C	Subpart C - FDA Accreditation of an Issuing Agency
21:8.0.1.1.15.3.1.1	SECTION 830.100	830.100 FDA accreditation of an issuing agency.
21:8.0.1.1.15.3.1.2	SECTION 830.110	830.110 Application for accreditation as an issuing agency.
21:8.0.1.1.15.3.1.3	SECTION 830.120	830.120 Responsibilities of an FDA-accredited issuing agency.
21:8.0.1.1.15.3.1.4	SECTION 830.130	830.130 Suspension or revocation of the accreditation of an issuing agency.
21:8.0.1.1.15.4	SUBPART D	Subpart D - FDA as an Issuing Agency
21:8.0.1.1.15.4.1.1	SECTION 830.200	830.200 When FDA will act as an issuing agency.
21:8.0.1.1.15.4.1.2	SECTION 830.210	830.210 Eligibility for use of FDA as an issuing agency.
21:8.0.1.1.15.4.1.3	SECTION 830.220	830.220 Termination of FDA service as an issuing agency.
21:8.0.1.1.15.5	SUBPART E	Subpart E - Global Unique Device Identification Database
21:8.0.1.1.15.5.1.1	SECTION 830.300	830.300 Devices subject to device identification data submission requirements.
21:8.0.1.1.15.5.1.2	SECTION 830.310	830.310 Information required for unique device identification.
21:8.0.1.1.15.5.1.3	SECTION 830.320	830.320 Submission of unique device identification information.
21:8.0.1.1.15.5.1.4	SECTION 830.330	830.330 Times for submission of unique device identification information.
21:8.0.1.1.15.5.1.5	SECTION 830.340	830.340 Voluntary submission of ancillary device identification information.
21:8.0.1.1.15.5.1.6	SECTION 830.350	830.350 Correction of information submitted to the Global Unique Device Identification Database.
21:8.0.1.1.15.5.1.7	SECTION 830.360	830.360 Records to be maintained by the labeler.

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