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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:
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.
Updated 9/5/2000
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Center for Devices and Radiological Health / CDRH