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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

House Discussion 德赢真人视讯Draft Released on Regulatory Approach for In Vitro Clinical Tests

On March 20,2017,Rep.Larry Bucshon (R-IN) and Rep.Diana DeGette (D-CO) released a discussion 德赢真人视讯draft of the Diagnostic Accuracy and Innovation Act (DAIA).  DAIA would regulate "in vitro clinical tests," defined in the discussion draft as a "laboratory test protocol or finished product" intended for clinical use "in the collection,preparation,analysis,or … Continue Reading

House Passes Fostering Innovation Act

This week,the U.S.House of Representatives unanimously passed the Fostering Innovation Act of 2015 (H.R.4139),bipartisan legislation that would extend for an additional five years the current exemption for emerging growth companies from certain internal corporate financial control requirements of the Sarbanes-Oxley Act.  The bill offers relief for medical technology and other emerging … Continue Reading

Senate HELP Committee Moves Forward With Companion Legislation to 21st Century Cures

As previously covered on this blog and in our alert,the U.S.House of Representatives passed the 21st Century Cures Act (H.R.6) in July 2015.  The U.S.Senate Committee on Health,Education,Labor,and Pensions (commonly referred to as the "HELP Committee") has worked on companion legislation to the House bill and,since February … Continue Reading