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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.
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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