January 19, 2011 / 6:04 PM / 9 years ago

U.S. FDA unveils medical device approval changes

WASHINGTON, Jan 19 (Reuters) - The U.S. Food and Drug Administration unveiled steps on Wednesday to streamline the approval process used for most medical devices and deferred decisions on the most contentious issues.

The FDA said it would ask the Institute of Medicine for input on seven proposals, including creation of a new class of devices that would require more data to win approval.

Twenty-five other changes to the abbreviated review process known as 510(K) will be put in place this year. (Reporting by Lisa Richwine; Editing by Tim Dobbyn)

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