Amendments to the MDR Regulation to Implement FDAMA Changes
The FDA Modernization Act of 1997 (FDAMA) changes to medical device adverse event reporting (MDR) became effective on February 19, 1998. On January 26, 2000, we published in the Federal Register changes to the implementing regulations, 21CFR 803 and 804, to reflect these amendments in the act. Also, Part 804 was removed.
The reporting changes are:
- Medical device manufacturers, importers, and distributors are no longer required to submit an annual certification statement.
- Domestic distributors no longer have to submit MDR reports, but they must continue to maintain records of adverse events.
- Importers continue to be subject to the remaining requirements of the MDR regulation, 21 CFR 803.
- User facilities now submit a report annually instead of semi-annually.
The MDR Rule changes became effective March 27, 2000.
Questions regarding MDR policy should be directed to the Reporting Systems Monitoring Branch via EMAIL at RSMB@CDRH.FDA.GOV or by phone at 301-594-2735, or by fax at 301-827-0038.