The 21st Century Cures Act (“the Act”) was passed by the U.S. House of Representatives on July 10, 2015, by a vote of 344-77. The Act includes provisions that would significantly affect the regulation of pharmaceuticals, biological products, and medical devices. We previously summarized the medical device provisions of a discussion draft of the Act that was circulated in January 2015 (see here).

The device provisions of the Act have been subject to many revisions since the discussion draft, including (i) the deletion of a placeholder for laboratory developed tests (LDTs), (ii) deletion of sections related to research use only products and surrogate endpoint qualification and utilization; and (iii) significant changes to the section relating to FDA authority over certain software.

If enacted, the Act would make changes to the standards and process for premarket review of new devices, the regulation of health software, and a number of other key medical device topics.

The Senate is currently working on parallel legislation to the Act. In addition, if not enacted during this Congress, it is possible that many aspects of the proposed legislation will be incorporated in the reauthorization of the Medical Device User Fee Amendments and associated legislation in 2017. We will continue to report on these legislative proposals as they are considered by the Senate.