Resources for Food and Drug Administration (FDA)

F.D.A. Tests on Devices Scrutinized

www.nytimes.com

A Congressional committee notified the Food and Drug Administration yesterday that, as a result of a recall by Medtronic of a product linked to patient deaths, it was reviewing how rigorously the agency required heart device components to be tested.

In a letter to the agency, Representative Henry A. Waxman, Democrat of California and chairman of the Committee on Oversight and Government Reform, asked agency officials a series of questions about its oversight of leads, the wires that carry electrical information between an implanted defibrillator and the heart.

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