Curriculum Vitae





Medical Device Failures - Check the FDA Files

Products used for medical diagnostics or therapy are regulated by the U.S. Food and Drug Administration (FDA). Manufacturers of medical devices are subject to rigorous registration and reporting requirements including annual reports filed with FDA revealing all incident reports, the results of failure investigations, and related litigation. These records may be obtained from the FDA through Freedom of Information requests, or from the manufacturer through discovery.

The Medical Device Regulations require health care professionals to report product failures to the FDA, which forwards them to the manufacturer for investigation. The FDA requires manufacturers to keep a written record of all product complaints and incidents, analyze the records for trends, investigate problems, and maintain these files for regular inspection by FDA investigators. These records can be a valuable resource for manufacturers to detect and correct quality problems quickly. Start at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM

The FDA may also make their own investigations into product failure reports, and sometimes requires manufacturers to take corrective action, initiate product recalls, or discontinue shipping the product.

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