Alert

Recommended Alerts

Sign Up For Alerts

FDA Updates Guidance on Cybersecurity Responsibilities for Medical Device Manufacturers

On April 8, 2022, the U.S. Food and Drug Administration (“FDA”) released a draft guidance document titled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.” The draft guidance, if finalized, would replace FDA’s 2014 final guidance document titled, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” which was discussed in a previous Ropes & Gray Alert.

Read More

Cookie Settings