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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 821 - Medical Device Tracking Requirements |
| Subpart A - General Provisions |
| § 821.1 - Scope. |
| § 821.2 - Exemptions and variances. |
| § 821.3 - Definitions. |
| § 821.4 - Imported devices. |
| Subpart B - Tracking Requirements |
| § 821.20 - Devices subject to tracking. |
| § 821.25 - Device tracking system and content requirements: manufacturer requirements. |
| Subpart C - Additional Requirements and Responsibilities |
| § 821.30 - Tracking obligations of persons other than device manufacturers: distributor requirements. |
| Subpart D - Records and Inspections |
| § 821.50 - Availability. |
| § 821.55 - Confidentiality. |
| § 821.60 - Retention of records. |