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Cybersecurity › Final Guidance › Medical Devices

Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk... more +
Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk management, global regulations, data protection, leaks, hacking, cyber insurance, compliance, HIPAA, and every other aspect of cybersecurity of import to corporate readers right now.   less -
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

King & Spalding

FDA Finalizes Premarket Cybersecurity Guidance for Medical Devices

King & Spalding on

On September 27, 2023, FDA finalized its guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (the “2023 Final Guidance”). The Final Guidance replaces...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

Hogan Lovells

Working Together: FDA Releases Final Guidance on Interoperability

Hogan Lovells on

On September 6, 2017, the Food and Drug Administration (FDA or the Agency) released its final guidance document, Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices (Final...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

Polsinelli

FDA Releases Final Cybersecurity Guidance for Medical Devices

Polsinelli on

Overview and General Principles - On October 2, 2014, the Food and Drug Administration (“FDA”) finalized guidance describing the FDA’s position on cybersecurity standards for medical devices. The guidance discusses...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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