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U.S. Department of Health and Human Services

Medical Devices

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Medical Device Reporting - Federal Register Notices

8/21/09 Draft Guidance for Industry, User Facilities, and Food and Drug Administration Staff: eMDR Electronic Medical Device Reporting; Availability Text PDF
8/21/09 Draft Guidance for Industry, User Facilities and FDA Staff: eMDR - Electronic Medical Device Reporting Text PDF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