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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 804 - MEDICAL DEVICE DISTRIBUTOR REPORTING |
| Subpart A - General Provisions |
| § 804.1 - Scope. |
| § 804.3 - Definitions. |
| § 804.9 - Public availability of reports. |
| Subpart B - Reports and Records |
| § 804.25 - Reports by distributors. |
| § 804.27 - Where to submit a report. |
| § 804.28 - Reporting form. |
| § 804.30 - Annual certification. |
| § 804.31 - Additional requirements. |
| § 804.32 - Supplemental information. |
| § 804.33 - Alternative reporting requirements. |
| § 804.34 - Written MDR procedures. |
| § 804.35 - Files. |