MDUFMA

FDA Commissioner: Device Approvals Process Set to Become Less Burdensome

August 24, 2012 | No comments

The head of the FDA, Commissioner Margaret Hamburg, ”sounds an optimistic tone” claiming approval process for medical devices is about to become considerably …

FDA and Industry Reach Agreement in Principle on Medical Device User Fees (MDUFMA)

February 1, 2012 | No comments

The FDA announced today that it reached an agreement on the third re-authorization of a medical device user fee program. The news follows the …