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Mar 131 min read

USFDA Med.Dev: Draft Guidance Select Updates for the Premarket Cybersecurity -Section 524B of the FD&C Act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

Oct 2, 20231 min read

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...

Apr 16, 20232 min read

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

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

Mar 30, 20232 min read

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...

May 11, 20221 min read

Cybersecurity of Legacy Medical Devices - Guidance-IMDRF

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

Apr 10, 20221 min read

FDA's Draft Guidance on Cybersecurity in MD: Quality System Consideration & Content of Premarket Sub

This draft guidance document is being distributed for comment purposes only.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...