While off-label use may be permissible, contraindicated use still has a strong regulatory boundary as reinforced by FDA guidance finalized in 2025.
The prediction that healthcare data would be aggressively targeted by ransomware attacks in 2017 has proven to be true. The malicious WannaCry ransomware attack spread to over 150 countries and ...
The FDA released their updated guidance on Cybersecurity in medical devices: Quality System Considerations and content for Premarket submissions at the end of June in 2025. In this guidance the FDA ...
The Federal Drug Administration’s current cybersecurity requirements are not appropriate for addressing and avoiding medical ...
The CORE-MD (Coordinating Research and Evidence for high-risk Medical Devices) consortium has published new consensus recommendations today in The Lancet Regional Health Europe, that set out ...
On November 21, 2024, FDA’s Center for Devices and Radiological Health (CDRH) announced a pilot program aimed at improving public notice about potentially high‑risk medical device recalls. The pilot ...
The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...
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