Approximately 8,000 new medical devices are marketed in the U.S. each year. The FDA receives approximately 200,000 adverse event reports received by the FDA yearly. Despite these reports, only 1,000 medical devices are recalled each year. Vital life-dependent medical devices are poorly tracked by the FDA and unnecessarily risk patients’ lives every day. The ATLA is seeking to end the disparity and is asking the FDA to be stricter with medical device recalls.
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