Sens. Chuck Grassley (R-Iowa), Herb Kohl (D-Wis.) and Richard Blumenthal (D-Conn.) have proposed legislation designed to improve post-market surveillance of medical devices to ensure patient safety without stifling innovation.
The Medical Device Patient Safety Act includes a requirement that the Food and Drug Administration assess device recalls, determine whether a recall was implemented effectively and terminate the recall once completed.
In addition, this legislation would allow the FDA to require collection of post-market data as a condition of approval and rescind a device's pre-market approval if the medical device company did not perform post-market studies as required.
The Medical Device Patient Safety Act includes a requirement that the Food and Drug Administration assess device recalls, determine whether a recall was implemented effectively and terminate the recall once completed.
In addition, this legislation would allow the FDA to require collection of post-market data as a condition of approval and rescind a device's pre-market approval if the medical device company did not perform post-market studies as required.
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