{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F7b489c80-d21e-4ca1-8d39-83ed06251031","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"What's New With PMAs","description":"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\u2019t look at it as the Kiss of Death. \n\nEmbrace 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!\n\nSome of the highlights of the show include:\n \n\u25cf\tEfforts are being made to entice acceptance of PMAs by requiring less clinical data and testing to get devices on the market sooner for customers.\n\u25cf\tClass III medical devices are often those that are life-sustaining, and making them safe is critical.\n\u25cf\tQuestions to consider: What is safety? How safe is safe? How much testing is enough?\n\u25cf\tFDA has an initiative to promote innovation and for companies to bring products to market in the United States.\n\u25cf\tIndustry statistics show that reporting issues may not be done or delayed when there are problems and malfunctions with devices; deadlines may be extended.\n\u25cf\tWhen you learn of problems with a device, you have a professional and ethical obligation to investigate and resolve them. Don\u2019t just put a Band-Aid on it!\n\u25cf\tFinding a new PMA pathway: One way for novel devices and one way for me-too devices \n\u25cf\tTake a risk-based approach to regulations and value predicates.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/4b649b3e-8c4b-42ff-9f1c-0fa456480e40/b24022ce-995c-46e9-a56e-f54740628959.jpg"}