FDA Guidance


FDA Distinguishes Medical Device Recall From Product Enhancement

Medical Device Guidance

Audet & Partners, LLP reports that the U.S. Food and Drug Administration (FDA) has issued new formal guidelines that are intended to clarify whether certain changes to marketed medical devices constitute a "recall" or "product enhancement."  This distinction is important to medical device manufacturers and marketers as "recalls" trigger specific reporting requirements with the FDA, while "product improvements" need not be reported to the FDA. The key element of guidance provided by the FDA concerns whether the product change includes "a... Read More