The US Food and Drug Administration has released a slew of updated guidances revamping its 510(k) review pathway, aimed at streamlining its work while also intending to help sponsors save time and resources.
The four guidances – aimed at clarifying the agency's thinking on its Special and Abbreviated 510(k) Programs, and explaining how to format traditional and abbreviated 510(k) submissions, as well as when the FDA would issue refuse-to-accept letters for 510(k) submissions – were posted online on 12 September
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?