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Home » Physicians, Patient Advocates Call for Changes to FDA Handling of Medical Device Failures
Physicians, Patient Advocates Call for Changes to FDA Handling of Medical Device Failures
September 23, 2005
Physicians and patient advocates are calling on the FDA to make fundamental changes to how the agency addresses medical device malfunctions — specifically by better defining product recalls, by clarifying when physicians should be alerted to device problems, and by concentrating more resources on monitoring the manufacture of particularly “high-risk” products such as implantable cardioverter-defibrillators (ICDs).