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USFDA Guidance: UDI Requirements for Combination Products and Cybersecurity for Medical Devices
In June 2025, the FDA released two impactful draft guidances that significantly affect medical device and combination product...

Sharan Murugan
Jun 293 min read
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USFDA Med.Dev: Draft Guidance Select Updates for the Premarket Cybersecurity -Section 524B of the FD&C Act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...

Sharan Murugan
Mar 13, 20241 min read
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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...

Sharan Murugan
Oct 2, 20231 min read
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IMDRF Guidance: CyberSecurity, Post-Market Surveillance, Personalized Medical Devices
Recently (IMDRF) released new four technical guidelines, "Personalized Medical Devices – Production Verification and Validation",...

Sharan Murugan
Apr 16, 20232 min read
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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...

Sharan Murugan
Mar 30, 20232 min read
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Cybersecurity of Legacy Medical Devices - Guidance-IMDRF
The International Medical Device Regulators Forum (IMDRF) Medical Device Cybersecurity Guide (MDCG) Working Group Proposed document...

Sharan Murugan
May 11, 20221 min read
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FDA's Draft Guidance on Cybersecurity in MD: Quality System Consideration & Content of Premarket Sub
This draft guidance document is being distributed for comment purposes only.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...

Sharan Murugan
Apr 10, 20221 min read
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