Coburn Chastises IOM For 510(k) Review, ‘Waste’ Of Taxpayer Money

Fiscal hawk Sen. Tom Coburn (R-OK) is criticizing the Institute of Medicine study of the FDA 510(k) device clearance process as a “waste” of taxpayer dollars after the agency flatly rejected the group of experts’ highly controversial recommendation to scrap the medical device review program. The 510(k) process assessment suggests a larger problem with IOM, which Coburn’s office says has been disproportionally subsidized with more than $300 million in taxpayer funding over a ten year period.

The IOM proposal — requested by FDA as part of an effort to reform the 510(k) process — garnered substantial opposition from industry and led FDA to immediately contend it would not seek dissolution of the program. FDA funded the study with $1.3 million.

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