The success of medical device firms is predicated upon incremental improvement of medical technology. New or modified devices are introduced onto the market through the 510(k) process. As innovation increases, companies are increasing the number of submissions they file and FDA is striving to increase the efficiency of the review process. FDA has issued many guidances and has changed policies over the last few years, of which, some affect the 510(k) program. During this session an expert panel will discuss the do’s and don’ts for 510(k) applications, FDA’s new Refuse to Accept policy, ecopy and the proposed When to File a 510(k) for Modifications to Legacy Marketed Devices, as well as industry strategies and reactions to these new review policies and proposals.
Meeting Challenges in FDA 510(k) Review
- On: September 30, 2014 at 3:30AM
- Category: Conferences