U.S. FDA (Food & Drug Administration) to Alter Rules on Medical Devices

[CC-Conrad Clyburn-MedForeSight]

Colleagues,

Thank you to MedTech-IQ members, Jonathan Rosen, PhD, Executive Director, Institute for Technology   Entrepreneurship and Commercialization, Boston University, www.bu.edu/itec, for the heads-up on this important FDA development ...

ENJOY!

CC

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... As reported in the Boston Globe ... Fielding complaints about poor communication and delays in reviewing and approving new products, the top US medical device regulator yesterday said his agency will overhaul its procedures to speed innovation while protecting patient safety...

... “We have not been clear about our expectations and we need to be,’’ Dr. Jeffrey E. Shuren said during a visit to the Boston area. Shuren, who took over as director of the Food and Drug Administration’s Center for Devices and Radiological Health in January, said regulators are committed to making “midcourse corrections,’’ including seeking more clinical data before devices win clearance....

... Hosting a “town meeting’’ for more than 400 medical device executives and other industry professionals at the Hilton Boston/Woburn hotel, Shuren heard plenty of criticism from leaders of start-up companies who said FDA delays, mixed signals, and lack of predictability were causing confusion and threatening their businesses...

... Shuren, a neurologist who completed his medical internship at Beth Israel Hospital and his residency at Tufts New England Medical Center, didn’t address the complaints of specific
companies. But in an interview after the session, his second of three town meetings scheduled across the country, he said the devices center has been working to improve its standards, training, and decision-making...

... An initial report on revamping the FDA’s approval process for medical devices, including changes in the development of clinical trials, is expected to be released for public comment in the coming weeks. New procedures could take effect later this year in what is known in the industry as the 510(k) medical device approval process....

Read on at: http://www.boston.com/yourtown/woburn/articles/2010/06/23/fda_to_al...

ENJOY!

CC

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[CC-Conrad Clyburn-MedForeSight]

MedTech-IQ member Martin von Dyck wrote:


" FDA must do something very soon! From my angle, Hydromer, being a value added provider to the medical device industry, I have observed a massive shift of new product development moving to Europe and Asia. 70% of my new clients are non-USA based. This may imply that soon the most advance medical devices will only be available in the EU and Asia. "