FDA's Top Medical Device Regulator Quits; More Turmoil on Horizon?by sterling1 on Aug 13, 2009 • 2:01 pm No Comments
Medical device manufacturers are already facing some uncertainty about impending rules for device identification. Now, they also face a new regulator.
In addition to likely facing a period of adoption of a new industry product marking standard from an FDA that is clearly beefing up its powers to do more — and do it faster and more effectively — comes news today that Daniel Schultz, who is the Food and Drug Administration’s top medical-device regulator, has resigned.
People come and people go. That’s not really the news that matters here. Instead, my take on the Wall Street Journal story is that Mr. Schultz may have been perceived as a little too manufacturer-friendly. If that’s true and if that’s the reason he’s been ousted (he’s saying it was “by mutual agreement” with FDA Commissioner Margaret Hamburg) it is a clear signal the FDA’s medical device regulator group will be a tougher, more demanding, more careful, and more rigorous organization.
In the end, for medical device manufacturers making the best products and following the rules — while competitors cut corners or play politics — this is a good thing.
- Medical Device and Product Litigation: The Lawyers Watch, Wait…
- Coming Medical Device Identification and Reporting Rules To Put Labeling Center Stage
- Patient Safety Coalition Pressuring FDA to Finalize Device ID Rule: GS1 Labels?
- Wristband Barcodes Drive Midland Memorial's E-Medical Records
- Loftware Invited to Feb. 12th FDA Workshop on Unique Device ID