FDA will refuse new medical devices for cybersecurity reasons on Oct. 1

Regulations requiring medical device manufacturers to ensure their products are “cybersecure” have been enforced by the US Food and Drug Administration (FDA). Effective as of 29 March, devices will be refused acceptance if these cybersecurity measures are deemed inadequate, and future submissions to the FDA must include detailed cybersecurity plans. These requirements aim to address ongoing issues of medical device security, which have received broad support from healthcare stakeholders seeking federal assistance.