MD&M East

Understanding FDA's QMSR and Cybersecurity Mandates for Medical Devices

Medical device manufacturers that want to avoid a long deficiency letter will want to pay close attention to FDA’s final cybersecurity guidance, updated in June 2025 (and again in February 2026).
Medical Device and Diagnostic Industry (MD+DI)

Cybersecurity Threats to Medical Devices: Navigating the Evolving Threat Landscape

The healthcare industry faces an unprecedented cybersecurity crisis as connected medical devices proliferate at an alarming ...
JD Supra

FDA finalizes cyber device “select updates” guidance, potentially affecting substantial equivalence findings for 510(k)s

The U.S. Food and Drug Administration (FDA) recently finalized its March 2024 select updates to its guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket ...
JD Supra

From Vulnerability to Violation: FDA Cybersecurity Requirements for Medical Devices and FCA Enforcement

In June 2025, the US Food and Drug Administration (FDA) issued a final guidance titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (2025 ...