Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 804 - MEDICAL DEVICE DISTRIBUTOR REPORTING |
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. |