FDA and key resources
FDA Web site -
Publications and databases
The main FDA Web site should be consulted for timely and updated information on product recalls, safety alerts, notices, public health advisories, and warnings for drugs, food, biologic products, and medical devices.
Sign up to receive email updates or search FDA publications/databases:
- Medical Device Recalls http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/default.htm
- Public Health Notification
Includes risks associated with use of medical devices as well as recommendations to avoid or reduce risk.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/
PublicHealthNotifications/default.htm - MedWatch Safety Alerts
Provides safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. MedWatch is the FDA's medical product reporting program for manufacturers, importers, consumers, health professionals and user facilities (including hospitals) to report serious adverse events or product problems associated with drugs or medical devices.
http://www.fda.gov/medwatch
FDA Enforcement Report
The FDA Enforcement Report is published weekly and contains information on actions taken in connection with the Administration's regulatory activities.
Report on FDA review of medical device safety
These are part of the findings in the GAO reports, and the GAO suggests that the FDA has used recall data to monitor individual recalls and target firms for inspections. However, it has not routinely analyzed recall data to determine whether there are systemic problems underlying trends in device recalls. Thus, the FDA has an opportunity to use recall data to proactively identify and address risks presented by unsafe devices.
- GAO report - Medical devices, FDA Should Enhance Its Oversight of Recalls
- Press release on GAO report on FDA recalls