Product Enhancements

News & Analysis as of

FDA Regulatory and Compliance Monthly Recap - October 2014

In This Issue: - FDA issues final guidance on discerning device recalls from market withdrawals related to medical device enhancements in apparent bid to appease industry concern over draft being overly broad, lacking...more

Medical Device Update: Distinguishing Medical Device Recalls from Medical Device Enhancements

On October 15, the U.S. Food and Drug Administration (FDA) issued the final guidance “Distinguishing Medical Device Recalls from Medical Device Enhancements.” This guidance revises and finalizes the draft version that...more

FDA Draft Guidance on Device “Product Enhancements” Could Lead to Increased Recalls

On February 22, 2013, the Food and Drug Administration (“FDA”) issued draft guidance explaining when a change to a medical device constitutes a medical device recall as opposed to a “product enhancement.” This draft guidance...more

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