Who’s afraid of the big, bad PMAs?


wolf uncertainty danger medtech PMA FDA

[Image from Unsplash]

PMAs at FDA are often a scary process for medical devices developers. But that doesn’t have to be the case, according to Michael Drues, a regulatory consultant based outside Boston who has worked with both medical device companies and FDA.

There are many myths around premarket approval, such as the idea that PMAs always require clinical data or that it isn’t possible to point to a predicate or substantial equivalence in the filing, Drues said during his latest podcast with Medical Design & Outsourcing.

FDA itself has been offering more guidance around the PMA process and proposing ways to make PMAs less scary for medtech innovators.

Listen to MDO’s newest podcast to find out more:

Inside Hologic's evolving definition of women's healthcare

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At DeviceTalks Boston, MacMillan will provide exclusive insights into the Massachusetts-based company and its evolving definition of women's healthcare. You don't want to miss it!


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