The U.S. FDA issued guidance on cybersecurity in medical devices on September 27, 2023, in response to rising cyber incidents, particularly in the healthcare sector. The guidance, which replaces the 2014 premarket submissions content, offers recommendations to ensure robust cybersecurity controls for device safety and effectiveness. It emphasizes premarket submissions should outline security objectives and confirms cybersecurity falls under device safety and quality system requirements.

GitHub hit by a sophisticated malware campaign as ‘Banana Squad’ mimics popular repos
The repository names are identical to other repositories, indicating typo-squatting. These repositories also contain search keywords and emojis, signifying potential AI use. ReversingLabs warns developers