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USFDA Med.Dev: Draft Guidance Select Updates for the Premarket Cybersecurity -Section 524B of the FD&C Act

Today (13 March, 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices and...

USFDA MD Guidance: Cybersecurity-Quality System Considerations & Content of Premarket Submissions

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released a final guidance "Cybersecurity in...

IMDRF Guidance: CyberSecurity, Post-Market Surveillance, Personalized Medical Devices

Recently (IMDRF) released new four technical guidelines, "Personalized Medical Devices – Production Verification and Validation",...

USFDA MD Guidance: Cybersecurity-Refuse to Accept Policy for Cyber Devices & Related Systems

Earlier today (30 March 2023) USFDA's Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research...

Cybersecurity of Legacy Medical Devices - Guidance-IMDRF

The International Medical Device Regulators Forum (IMDRF) Medical Device Cybersecurity Guide (MDCG) Working Group Proposed document...

FDA's Draft Guidance on Cybersecurity in MD: Quality System Consideration & Content of Premarket Sub

This draft guidance document is being distributed for comment purposes only. Cybersecurity incidents have rendered medical devices and...