FDA pledges support for med tech initiative
The Food and Drug Administration says it will work with medical device manufacturers on a public-private partnership designed to speed up the development of new medical technology.
The agency says it hopes to offer guidance to the Medical Device Innovation Consortium, a new industry-backed group that aims to simplify the design and testing of medical devices.
FDA Commissioner Dr. Margaret Hamburg notes that many medical device companies are small businesses and don't have the research budgets to find more effective ways of testing their products. She said the new group would pull information and ideas from industry, government and academia.
The agency's pledge follows criticism from device industry advocates, who have lobbied Capitol Hill for more than a year to fix an FDA review process which they say is forcing some companies out of business.
Medical device makers have criticized the FDA for an overly burdensome system of reviewing devices, which they claim slows down development of important new therapies. They point to some device companies that are launching their products in Europe first, although experts agree the bar for approval is lower overseas.
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