fda cybersecurity

The FDA Finally Suggests Meaningful Action to Secure Medical Devices

by James Scott, Sr. Fellow, Institute for Critical Infrastructure Technology Healthcare depends on the crucial medical devices essential for the treatment and diagnosis of illness and disease. The Food and Drug Administration (FDA) regulates over 190,000 different devices, which are manufactured by more than 18,000 firms in more than 21,000 medical device facilities worldwide. Digital .. read more

ICIT Analysis: FDA Guidance on Medical Device Cyber Security

This Institute for Critical Infrastructure Technology blog post, entitled “Assessing the FDA’s Cybersecurity Guidelines for Medical Device Manufacturers: Why Subtle “Suggestions” May Not Be Enough” is an objective analysis of the recent Food and Drug Administration (FDA) “Draft Guidance for Industry and Food and Drug Administration Staff.” The guidance advises medical device manufacturers to address .. read more