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Fenwick & West LLP

Your Digital Health Regulation Questions Answered

Fenwick & West LLP on

regulators. The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices, including software-as-a-medical-device (SaMD). Several years ago, the FDA upgraded its...more

Hogan Lovells

Guidances galore: FDA finalizes multiple digital health guidance documents

Hogan Lovells on

On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released a series of guidance documents addressing the agency's current views on software regulation following the changes implemented in the 21st...more

King & Spalding

FDA Tackles Digital Health Software Devices with New Pre-Certification Review Plan

King & Spalding on

On January 7, 2019 the U.S. Food and Drug Administration (“FDA”) issued three new documents related to the Agency’s Software Precertification (“Pre-Cert”) Pilot Program. These documents include (1) the Developing a Software...more

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