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FDA Cannot Meet Requirements For Inspections Of Medical Device Manufacturers

Armen Hareyan's picture

FDA cannot meet requirements for inspections ofmedical device manufacturing facilities in the U.S. and abroad, according to a Government Accountability Office report scheduled for release on Tuesday at ahearing of the House Energy and Commerce Oversight and Investigations Subcommittee, the Wall Street Journalreports (Wilde Mathews, Wall Street Journal, 1/29).

The report found that inspections of all medical device manufacturingfacilities abroad would take FDA 27 years. FDA computer systems cannotdetermine the number of medical device manufacturing facilities abroad thatexport products to the U.S. or which facilities the agency has inspected, thereport found (Harris, New York Times, 1/29). According to the report,FDA inspects U.S.facilities that manufacture the highest-risk medical devices once every threeyears and facilities that manufacture moderate-risk medical devices once everyfive years. "Both are supposed to be looked at every two years," the Journalreports.

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The "GAO testimony on medical devices will be part of the hearing'sbroader effort to highlight an issue that has turned up in reports andcritiques over the past few years: concerns the FDA's resources and technologyaren't enough to meet its regulatory responsibilities to oversee drugs, foodand other products," the Journal reports (Wall StreetJournal 1/29).

The report also examined FDA oversight of imported foods and medications.Inspections of all food processing facilities abroad would take FDA 1,900years, and inspections of all medication manufacturing facilities abroad wouldtake the agency 13 years, the report found. The report attributed the problemswith inspections of such facilities to inadequate FDA computer systems (NewYork Times, 1/29). House Energy andCommerce CommitteeChair John Dingell (D-Mich.) has introduced legislation that seeks to improveFDA oversight of imported foods and medications through new industry fees (WallStreet Journal 1/29).

Reprintedwith permission from kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, and sign upfor email delivery at kaisernetwork.org/email . The Kaiser Daily Health PolicyReport is published for kaisernetwork.org, a free service of The Henry J.Kaiser Family Foundation.