Cyber incidents are on the rise with no signs of slowing down, particularly in the healthcare industry. To combat this trend, on September 27, 2023, the U.S. Food and Drug Administration (FDA) released guidance on cybersecurity in medical devices for quality system considerations and on premarket submissions. The guidance is intended to replace the FDA’s 2014
medical devices
FDA Provides Data Security Guidance for Medical Device Manufacturers
By Joseph J. Lazzarotti on
Big Data’s impact on medical devices pushes FDA to propose draft guidelines for cybersecurity.
Continue Reading FDA Provides Data Security Guidance for Medical Device Manufacturers