FDA Is Revamping Clearance Procedures for Medical Devices

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WASHINGTON—The Food and Drug Administration is significantly revamping a approach it clears many medical inclination for U.S. marketing, formulation to rest distant reduction on comparisons with most comparison products already on a market.

This faith by a sovereign group has been regarded as one of a weaknesses in a approach it allows medical inclination to be sole in a U.S., heading to problem inclination like poor steel hip implants and bloodstream filters that fractured. Instead of insisting on full studies of such products, a FDA has allowed…

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