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FDA > CDRH > Medical Device Safety > Report a Problem

Report a Problem

Health professionals and consumers should submit reports of significant device adverse events or product problems to FDA via the MedWatch program in one of the following ways:

  • online at the MedWatch site (get the online MedWatch form and instructions)
  • by telephone at 1-800-FDA-1088;
  • by fax at 1-800-FDA-1078; or
  • by mail to MedWatch, Food and Drug Administration, HF-2, 5600 Fishers Lane, Rockville, MD 20857.

If you’re not sure whether you need to report an incident, you may always contact CDRH directly by email or by phone at 301-594-2735 or by fax at 301-827-0038.

Updated March 15, 2006

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