510(k)

U.S. FDA Issues Draft Guidance on Special 510(k) Program

The U.S. Food and Drug Administration (FDA) has published a draft guidance intended to...

FDA Issues Updated Guidance on Addressing Medical Device Changes

In an effort to reduce confusion among manufacturers whose medical devices are subject to...

FDA Proposes Exempting Some Class II Devices from 510(k) Requirements

The U.S. Food and Drug Administration (FDA) has proposed exempting several hundred medical devices...

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