FDA Aims To Speed Reviews Of New, Low-Risk Devices

Law360, New York (September 30, 2011, 6:28 PM EDT) -- The U.S. Food and Drug Administration on Friday released a draft guidance meant to streamline the process for reviews of innovative, low- or moderate-risk medical devices, which the agency says has become too unwieldy.

The proposed process could shave up to 90 days off reviews, the FDA said.

In order to win clearance to market a new or altered medical device, a manufacturer normally has to show the FDA that its device is substantially similar to one that's already been cleared by the agency.

That poses...
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