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发帖数: 961 | 1 IMARC Research - Friday, September 16, 2011
On September 6th, the FDA announced two new training programs designed to
improve the consistency of medical device reviews by enhancing the skills of
those reviewing premarket applications at the Center for Devices and
Radiological Health (CDRH).The 18-month training program will apply to all
new device reviewers from the CDRH’s anesthesia, general hospital,
infection control and dental devices divisions.Dr. Jeffrey Shuren indicates
the investment is intended to help reviewers handle the range of issues that
arise during premarket device reviews.
The House Energy & Commerce Committee’s Health panel plans to spend the
fall focusing on tweaking the FDA regulatory process for medical devices and
prescription drugs. According to a recently released agenda, this is
intended to help get a competitive edge in overseas markets with more
favorable regulatory conditions.
Many feel the lack of predictability and consistency at the FDA is pushing
many new product approvals to Europe, causing the U.S. its leadership in the
medical device industry. There have been demands by many industry leaders
for consistency to help remove the uncertainty many face in the med-tech
industry.
Do you feel the steps being taken by the FDA are helping address the
concerns of the medical device industry? Let us know what you think.
http://www.imarcresearch.com/_blog/IMARC/post/FDA_Reviewers_Get |
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