Devices & Diagnostics, Policy

Analyst: Expect more PMA applications post IOM’s 510(k) assessment

The U.S. Food and Drug Administration will most likely not scrap the 510(k) system as […]

The U.S. Food and Drug Administration will most likely not scrap the 510(k) system as the Institute of Medicine called for, but one analyst predicted that the number of devices requiring pre-market approvals will spike as a result of IOM’s recommendations for overhauling medical device regulation.

Morgan Stanley analyst David Lewis said that the medical device industry should expect that the FDA will require more clinical and pre-clinical data for 510(k) submissions.

He also predicted that modifying and augmenting an existing device would become more “rigorous,” thereby slowing new product enhancements.

Lewis said that there will be clarity over the 510(k) process in the short term and that could provide some relief on how the program is administered.

That will certainly be music to the ears of the medical device industry that has long complained that the FDA has been inconsistent and unpredictable in reviewing medical devices through the 510(k) system, thereby slowing innovation and introduction of new, innovative medical devices.

But while there is good news short term, long term Lewis expects that getting approval from the FDA will become more expensive. He advised device makers to rethink their R&D investment, especially considering pricing pressures on their products.

Read Lewis’ report here.

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