MedCon 2013, Xavier University, Cincinatti, OH.
Industry has ongoing concerns that the 510(k) review process continues to delay approvals and stifle innovation. This session will discuss FDA's recently released refusal to file guidance and common quality issues with 510(k) submissions. The discussion will include FDA performance metrics under the current regulations and changes implemented with MDUFMA III. An industry perspective will be presented using representative case studies.