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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:
Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at cnewmarker@wtwhmedia.com.
