An Institute of Medicine report criticized the Food and Drug Administration for lacking procedures to monitor safety studies conducted by manufacturers after a medical device is on the market. Congress should require that the FDA establish a reliable tracking system and make information collected by the system available to patients, providers and researchers, according to the committee that wrote the report. The committee also recommended that Congress give the FDA the authority to require post-market studies as a condition of marketing approval. In some respects, however, substantial progress in detecting and preventing problems will depend on the efforts of hospitals, clinicians, devicemakers and others to improve their own monitoring programs, the committee said. The report, requested by Congress, was supposed to focus on devices for children, but the committee's recommendations were broader. At deadline, the report was not available online. Read the National Academies' news release. -- by Cinda Becker
FDA urged to track post-market device studies
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