The US Food and Drug Administration has announced five more device classifications, a crucial step that allows products that reached market via the de novo process to be used as predicate devices in future 501(k) applications. The agency has been on a bit of a classification spree in the last few months, with the total number of products gaining class II status nearing two dozen.
The latest list was diagnostics-heavy, with four of the products fitting the category. Notably, two were screening tests used to...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?