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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 830 - Unique Device Identification |
| 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. |