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CDRH Releases Guidance Priorities for Fiscal 2020

November 6, 2019

CDRH released a list of priority guidances it plans to publish during fiscal 2020, including an “A-list” of final and draft guidances.

The A-list priorities for final guidances include: Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies; 510(k) Third Party Review Program; and Safer Technologies Program for Medical Devices, among others.

The A-list draft guidance for the year ahead include: Labeling and Informed Decision Checklist for Breast Implants; Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; and Distinguishing between Medical Device Servicing and Remanufacturing.

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