How do you feel about pre-market approval (PMA) for Class III medical devices? Most businesses are not excited about products that require a PMA. But don’t look at it as the Kiss of Death. Embrace the PMA concept as a way to bring novel and unique devices to the market. Mike Drues of Vascular Sciences and I explore the topic of PMA. Lives depend on it! Some of the highlights of the show include: ● Efforts are being made to entice acceptance of PMAs by requiring less clinical data and testing to get devices on the market sooner for customers. ● Class III medical devices are often those that are life-sustaining, and making them safe is critical. ● Questions to consider: What is safety? How safe is safe? How much testing is enough? ● FDA has an initiative to promote innovation and for companies to bring products to market in the United States. ● Industry statistics show that reporting issues may not be done or delayed when there are problems and malfunctions with devices; deadlines may be extended. ● When you learn of problems with a device, you have a professional and ethical obligation to investigate and resolve them. Don’t just put a Band-Aid on it! ● Finding a new PMA pathway: One way for novel devices and one way for me-too devices ● Take a risk-based approach to regulations and value predicates.