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  1. Medical Device Reporting (MDR): How to Report Medical Device Problems

Medical Device Reporting - Federal Register Notices

DateTitleText FormatPDF Format
8/21/09Draft Guidance for Industry, User Facilities, and Food and Drug Administration Staff: eMDR Electronic Medical Device Reporting; AvailabilityTextPDF
8/21/09Draft Guidance for Industry, User Facilities and FDA Staff: eMDR - Electronic Medical Device ReportingTextPDF
8/21/09Medical Device Reporting: Electronic Submission RequirementsTextPDF
9/17/08Medical Devices; Medical Device Reporting; Baseline Reports; Confirmation of Effective DateTextPDF
6/13/08Medical Devices; Medical Device Reporting; Baseline Reports (Direct final rule)TextPDF
6/13/08Medical Devices; Medical Device Reporting; Baseline Reports; Companion to Direct Final Rule (Proposed rule)TextPDF
2/28/05Federal Register: Medical Devices; Medical Device Reporting - Direct Final RuleTextPDF
02/17/04Federal Register, Medical Devices; Revised MedWatch Forms; AvailabilityTextPDF
02/25/04Federal Register, Medical Devices; Revised MedWatch Forms; Availability - CorrectionTextPDF
12/11/95Federal Register, Final Rule: Medical Devices; Medical Device User Facility and Manufacturer Reporting, Certification and RegistrationTextPDF
05/08/01Medical Devices; Medical Device Reporting Regulations; Technical AmendmentTextPDF
01/26/00Federal Register, Final Rule: Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, Distributor ReportingTextPDF
03/20/97Federal Register, Final Rule: Medical Device Reporting; Annual CertificationText 
07/31/96Federal Register, Final Rule: Medical Devices; Baseline Reports; Stay of Effective DateTextPDF
07/23/96Federal Register, Proposed Rule: Medical Devices; Reporting; Certification and U.S. Designated AgentsTextPDF
07/23/96Federal Register, Final Rule: Medical Devices; Stay of Effective Date; Revocation of Final RuleTextPDF
04/11/96Federal Register, Final Rule: Medical Devices; Medical Device User Facility and Manufacturer Reporting, Certification and RegistrationTextPDF