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Software › CDRH

Epstein Becker & Green

Unpacking Averages: CDRH Recognition of Consensus Standards Appears to Overlook Software

Epstein Becker & Green on

For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical device submissions....more

Sheppard Mullin Richter & Hampton LLP

FDA Appointment Signals Increased Attention on Medical Device Cybersecurity

Sheppard Mullin Richter & Hampton LLP on

At the beginning of February, the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) appointed Professor Kevin Fu as the first ever Acting Director of Medical Device Cybersecurity. Fu’s...more

Hogan Lovells

CDRH plan for FY-2021 guidance prioritizes cybersecurity, CDS software, COVID-19 updates

Hogan Lovells on

On October 16, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) announced the list of priority guidance documents that CDRH intends to publish this fiscal year (FY-2021)....more

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