Report: FDA should start over on device approval process

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Congress is beginning debate on a major FDA reauthorization that needs to pass next year. The bill often becomes a vehicle for broader policy changes and could provide an opening for changes in the 510(k) process.

The industry's leading trade group, however, said following the IOM's recommendations would be a "disservice" to the public.

"The report’s conclusions do not deserve serious consideration from the Congress or the Administration," the Advanced Medical Technology Association said in a statement.

The FDA also disagreed with the IOM's recommendations.

“FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs,” said Jeffrey Shuren, the agency's top devices official.

Devices cleared through 510(k) don't have to prove that they're safe and effective — only that they are "substantially equivalent" to another product that the FDA has already allowed on the market.

The IOM committee said the process can't be fixed as long as equivalence — rather than safety and effectiveness — is the standard.

"The current 510(k) process is flawed based on its legislative foundation," the IOM committee said. "Rather than continuing to modify the 35-year-old 510(k) process, the IOM concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle."



— This post was updated at 11:20 a.m.