[FEATURED] New 510(k) Modifications Guidance May Prompt New Submissions
US FDA has made at least nine changes releasing a final 510(k) modifications guidance on Oct. 24. This new guidance showcases useful flowcharts to help device sponsors determine when a […]
What the FDA Reauthorization Act Means for Pharmaceuticals and Medical Devices
On August 18th, President Trump signed the FDA Reauthorization Act (FDARA). Besides reauthorizing user fees for pharmaceuticals and medical devices for five years the law also focuses on many aspects […]
