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Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

Ballard Spahr LLP on

The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

Hogan Lovells

FDA spells out electromagnetic compatibility info needed in medical device premarket submissions

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently issued the final guidance, “Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug Administration Staff,” which details the...more

Morgan Lewis

FDA Issues Final Guidance on Postmarket Cybersecurity

Morgan Lewis on

Agency establishes a risk-based framework for assessment of postmarket cybersecurity risks for medical devices. On December 28, 2016, FDA issued a final guidance titled “Postmarket Management of Cybersecurity in Medical...more

Parker Poe Adams & Bernstein LLP

New FDA Cybersecurity Guidance for Medical Device Manufacturers

Parker Poe Adams & Bernstein LLP on

Last month, the U.S. Food and Drug Administration issued its final guidance, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” Those guidelines make non-binding recommendations on the...more

King & Spalding

Medical Devices and Cybersecurity Risks - DHS investigates at-risk devices

King & Spalding on

On October 2, 2014, the U.S. Food and Drug Administration (FDA) issued its final guidance on cybersecurity for medical device manufacturers, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical...more

Mintz - Privacy & Cybersecurity Viewpoints

A Different Kind of “Virus”: FDA Follows NIST Framework in Cybersecurity Guidance for Medical Devices

Mintz - Privacy & Cybersecurity Viewpoints on

In past posts we’ve taken a close look at the Framework for Improving Critical Infrastructure Cybersecurity put forth by the National Institute of Standards and Technology (NIST), exploring its wide-ranging implications for...more

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