US FDA's recent congressionally directed actions to exempt reams of devices from 510(k) requirements may have less of an impact on industry and agency workloads than the top-line numbers suggest, according to an analysis performed by Medtech Insight in collaboration with regulatory intelligence firm Graematter Inc. But there are pockets of companies and clinical specialties where the effects might be more pronounced, the analysis found.
In July, FDA issued a Federal Register notice listing several hundred class II devices that it was exempting from 510(k) requirements. (Also see "US FDA: 510(k)-Exempt Class...
The actions were required by a provision in the December-enacted 21st Century Cures Act intended to "decrease regulatory burdens on the medical device industry" and "eliminate private costs and expenditures...
