The U.S. Food and Drug Administration has issued new draft guidance that would exempt certain Class I and II medical devices from premarket submission requirements.
The FDA has identified certain Class II medical devices for which the regulatory agency believes a 510(k) review is not necessary to assure safety and effectiveness before these devices enter the marketplace, and certain Class I medical devices which it believes no longer meet the reserved criteria of the Federal Food, Drug, and Cosmetic Act .
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