User Fees for Medical Devices: Third Time Lucky?
John R. Graham, Director, Health Care Studies
Congress recently passed, almost unanimously, S.3187, the Food and Drug Administration Safety and Innovation Act. Title II of the Act comprised the third reauthorization of user fees for the medicaldevice industry, for fiscal years 2013 through 2017.
A product of lengthy negotiations between the medical-device industry and the Food and Drug Administration, the amendments commit the FDA to a number of new performance goals.
Read the full report here: www.pacificresearch.org/docLib/20120702_HPPJune.2012_F.pdf.
- Medical Device ” The Senate Passes Unparalleled Medical Device User Fee Act (earlsview.com)
- Governmental Oversight of Potentially Dangerous Medical Devices – US Politics Today (earlsview.com)
- FDA Proposes Device ID Regulations for Medical Dev – TMD – Today’s Medical Developments (earlsview.com)
- The Senate Passes Unparalleled Medical Device User Fee Act (depuyrecall.wordpress.com)
- FDA releases proposed UDI rule; reaction generally positive (earlsview.com)
- New FDA guidance on considerations used in device approval (earlsview.com)
- Rottenstein Law Group Hopes Final Version of Medical Device User Fee Act Improves FDA’s Medical-Device Approval Process (prweb.com)
- FDA Cuts a Deal to Fast Track Drugs and Devices (earlsview.com)
- Mr. President, sign that user fee bill (medcitynews.com)
- Quick Senate Passage Puts House Under Pressure to Act on FDA User Fee Legislation (thebigredbiotechblog.typepad.com)