September 23,2009

Grassley applauds FDA commissioning of IOM study of system reviewing medical device safety

WASHINGTON --- Senator Chuck Grassley said it was good news that the Food and Drug Administration has commissioned the Institute of Medicine to examine the agency’s 510(k) system for clearing medical devices.

The 501(k) system is used for reviewing most devices approved by the agency. It is less stringent than FDA’s premarket approval process used in reviewing high risk devices, such as implantable defibrillators and pacemakers.

A provision requiring the FDA to commission a study was included in legislation introduced last April by Grassley and the late Senator Ted Kennedy. Their bill, the Drug and Device Accountability Act (S.882), would give the FDA more resources to inspect domestic and foreign manufacturers of prescription drugs and devices.

“A study by the well regarded Institute of Medicine will provide valuable information to improve the FDA’s review of medical devices. Questions have been raised about the agency’s work in this area,” Grassley said.
A January 2009 report of the Government Accountability Office detailing concerns about the FDA’s review process for medical devices is attached.

Grassley has conducted active oversight of the FDA during the last five years. He’s advocated greater independence in post-market surveillance and sought greater transparency and accountability in the drug and device approval process.