Tag Archives: user fees

FDARA Reauthorizes Device User Fees and Amends Key Device Provisions of FDCA

Last month, President Trump signed the FDA Reauthorization Act of 2017 (FDARA).  FDARA reauthorizes the Medical Device User Fee Amendments (MDUFA), allowing FDA to collect medical device user fees for fiscal years 2018 to 2022 after FDA’s current user fee authority ends on September 30, 2017.  Notably, the reauthorized MDUFA adds a substantial new user … Continue Reading

Legislation Introduced to Protect Medical Devices from Effects of Sequestration

Under the Budget Control Act, popularly known as the sequester, mandatory spending cuts are in effect at agencies across the federal government.  The Act was enacted as part of negotiated compromise in the summer of 2011 to secure an increase in the federal debt ceiling.  As part of the debt limit increase, Congress established the … Continue Reading