What's New With PMAs - a podcast by Greenlight Gurus Jon Speer + Medical Device Quality Regulatory Leaders, Entrepreneurs, Consultants, R&D Engineers
from 2019-11-07T15:07:09
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.
Further episodes of Global Medical Device Podcast powered by Greenlight Guru
Further podcasts by Greenlight Guru's Jon Speer + Medical Device Quality Regulatory Leaders, Entrepreneurs, Consultants, R&D Engineers