FDA issues draft guidance on device changes that warrant new premarket review

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA issues draft guidance on device changes that warrant new premarket review

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FDA issues draft guidance on device changes that warrant new premarket review

07/26/2011 09:23 AM EDT

The U.S. Food and Drug Administration today issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission.

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