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 ...

The Food and Drug Administration issued a draft of updated recommendations intended to clarify when manufacturers should report medical device changes to the agency. The draft recommendations contain ...

After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...

FDA alerted healthcare providers this week about import alerts for certain medical devices manufactured in Japan by Olympus Medical Systems and its subsidiaries. “Despite extensive and ongoing efforts ...

FDA classifies medical devices based on the type of device and the level of risk it poses Three main FDA clearances for medical devices are 510(k), de novo and pre-market approval Several ASX ...