Grassley Applauds FDA Commissioning Of IOM Study Of System Reviewing Medical Device Safety

Press Release

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.

Here is the section of S.882 that called for the study:

SEC. 143. STUDY BY THE INSTITUTE OF MEDICINE REGARDING THE REVIEW OF MEDICAL DEVICES.

(a) In General- The Secretary of Health and Human Services shall enter into a contract with the Institute of Medicine to conduct a study to--

(1) evaluate the organizational structure and operations of the Food and Drug Administration with respect to the review of medical devices for clearance under section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k)) and for premarket approval under section 515 of such Act (21 U.S.C. 360e);

(2) evaluate the analytical and methodological tools used by such Administration to conduct such reviews; and

(3) identify strengths, weaknesses, and limitations of the system used by such Administration to conduct such reviews.

(b) Report- Not later than September 31, 2010, the Institute of Medicine shall complete the study described under subsection (a) and submit to the Secretary of Health and Human Services, the Committee on Health, Education, Labor, and Pensions and the Committee on Finance of the Senate, and the Committee on Energy and Commerce of the House of Representatives a report that--

(1) describes the findings of such study; and

(2) makes recommendations regarding the organization structure and operations of the Food and Drug Administration, legislation, and regulation to improve or enhance the review of medical devices by such Administration.

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