| 8/21/09 | Draft Guidance for Industry, User Facilities, and Food and Drug Administration Staff: eMDR Electronic Medical Device Reporting; Availability | Text | PDF |
| 8/21/09 | Draft Guidance for Industry, User Facilities and FDA Staff: eMDR - Electronic Medical Device Reporting | Text | PDF |
| 8/21/09 | Medical Device Reporting: Electronic Submission Requirements | Text | PDF |
| 9/17/08 | Medical Devices; Medical Device Reporting; Baseline Reports; Confirmation of Effective Date | Text | PDF |
| 6/13/08 | Medical Devices; Medical Device Reporting; Baseline Reports (Direct final rule) | Text | PDF |
| 6/13/08 | Medical Devices; Medical Device Reporting; Baseline Reports; Companion to Direct Final Rule (Proposed rule) | Text | PDF |
| 2/28/05 | Federal Register: Medical Devices; Medical Device Reporting - Direct Final Rule | Text | PDF |
| 02/17/04 | Federal Register, Medical Devices; Revised MedWatch Forms; Availability | Text | PDF |
| 02/25/04 | Federal Register, Medical Devices; Revised MedWatch Forms; Availability - Correction | Text | PDF |
| 12/11/95 | Federal Register, Final Rule: Medical Devices; Medical Device User Facility and Manufacturer Reporting, Certification and Registration | Text | PDF |
| 05/08/01 | Medical Devices; Medical Device Reporting Regulations; Technical Amendment | Text | PDF |
| 01/26/00 | Federal Register, Final Rule: Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, Distributor Reporting | Text | PDF |
| 03/20/97 | Federal Register, Final Rule: Medical Device Reporting; Annual Certification | Text | |
| 07/31/96 | Federal Register, Final Rule: Medical Devices; Baseline Reports; Stay of Effective Date | Text | PDF |
| 07/23/96 | Federal Register, Proposed Rule: Medical Devices; Reporting; Certification and U.S. Designated Agents | Text | PDF |
| 07/23/96 | Federal Register, Final Rule: Medical Devices; Stay of Effective Date; Revocation of Final Rule | Text | PDF |
| 04/11/96 | Federal Register, Final Rule: Medical Devices; Medical Device User Facility and Manufacturer Reporting, Certification and Registration | Text | PDF |
