FDA Issues Long-Awaited Guidance On Device Security For Premarket Submissions, Seeks Industry Feedback
The US agency says increasing threats require an updated approach
Executive Summary
The US FDA’s 8 April draft guidance on device security replaces the agency’s 2018 guidance on the topic to better meet current cyber challenges.
You may also be interested in...
Digital Health Regulations: A Year In Review
RQM’s Allison Komiyama and Kevin Go summarized up the year’s changes to digital health regulation and outlined what to expect in the coming year.
FDA’s Schwartz Says New Draft Cybersecurity Guidance Addresses Emerging Threats
Suzanne Schwartz, director of the US FDA’s Office of Strategic Partnerships and Technology Innovation, tells Medtech Insight that recent cyberattacks have crippled hospitals networks, putting many patients at risk.
Alarming Rise Of Diabetes in Several US States, Study Shows
A study of diabetes rates across the US over four years reveals significant increases in the disease in many states. Tobias Oerum, diabetes advocate and cofounder of the company that conducted the study, discussed the data and some of the factors contributing to this troubling trend with Medtech Insight.