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7.29.11 | Arundhati Parmar Source: MedCityNews

510(k) approval process is too big to fail no matter how flawed it may be

The Institute of Medicine released its report Friday calling on the U.S. Food and Drug Administration to scrap the 510(k) certification for medical devices altogether. But could it be that the 510(k) system is too big too fail?

In an interview following the release of the report, one of the 11-member IOM panel that provided the non-binding recommendations told MedCity News that the FDA has been “heroically” trying to make sure that products cleared through the 510(k) process are both “safe and effective.” But the FDA has been given the wrong tool to make that determination.

Making that judgment on the basis of “substantial equivalance” means that FDA is “guaranteed to get the wrong answer,” said William Vodra, an IOM panelist and retired attorney with Washington, D.C. law firm Arnold and Porter. The question of substantial equivalence is wrong because itessentially implies that as long as products are similar to a predicate device, it meets the threshold of safety and effectiveness.

“FDA cannot polish their shoes without a shoe polishing kit,” Vodra said. “That’s the problem.”

Instead of asking for substantial equivalence, the question that FDA should be authorized to ask is “do the benefits of the products outweigh the known and potential risks?” Vodra said. He added that the answer should come from knowledge of the product at the time of clearance and from FDA’s ability to gather more information after the product enters the market and its ability to act on the information.

“We are trying to link pre and post market information together,” Vodra said.

It is notable that IOM, the only party involved in the process that could be considered a scientifically neutral observer found the 510(k) process so flawed as to recommend its elimination.

But FDA has invested too much time and resources on reforming the 510(k). Earlier this week they issued the first draft guidance of when a device may require a new 510(k) submission.

And even before the IOM issued its report, the FDA wasalready distancing it from the panel and its forthcoming recommendations.

The industry has hit back hard saying that Congress won’t seriously consider recommendations to go back to the drawing board and craft a new system. And Medtronic, the world’s largest medical device company, said that the company does not support scrapping the 510(k).

Which goes back to the initial question, “is 510(k) too big too fail?”

It certainly appears to be so.

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