Category: Draft Guidances

Draft Guidances

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FDA Takes Steps to Modernize 510(k) Medical Device Program

The U.S. FDA has announced that, as a first step toward implementation of the recently established Safety and Performance Based Pathway for medical devices, the agency is issuing draft guidances outlining the recommended premarket performance criteria and testing methodologies for four specific types of devices.

Draft Guidances

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FDA Publishes New Draft Guidance Regarding Product Recalls

U.S. FDA Commissioner Scott Gottlieb, MD, announced that the agency has developed new policy steps for strengthening product recalls. Specifically, Gottlieb revealed, the FDA has published a draft guidance that better explains the FDA’s policy on public warnings and device recall notifications—in an effort to provide more timely information to consumers.

Draft Guidances

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