(March 11, 2016) The U.S. Senate Health, Education, Labor & Pensions committee approved a bill to expand an expedited review program for FDA approval of certain medical devices. The bill, S. 1077 “A bill to provide for expedited development of and priority review for breakthrough devices,” is aimed at expediting the approval process for ‘breakthrough’ medical devices, and builds on the FDA’s Expedited Access Pathway, which was implemented in 2015.
According to the bill, ‘Breakthrough’ medical devices treat or diagnose life-threatening or irreversible diseases for which no approved alternatives exist, or offer significant advantages over existing technologies. The streamlined review process for these devices would require shorter and smaller clinical trials to show a device’s success, and would implement quicker compliance time-frames. Expedited review would be available to all classes of medical device; currently only class III, or high risk, devices are able to receive expedited review. A similar program is available for FDA approval of drugs designated as “breakthrough therapies.
Some advocacy groups have expressed concerns that patients may be put at risk if the FDA is not thorough enough during the quickened approval process. Proponents of the bill counter that an expedited review process will allow patients more timely access to potentially life-saving devices.
The bill is part of a larger effort by the National Institutes of Health to increase medical research. The NIH hopes that streamlining the review process for revolutionary medical devices will lead to increased private sector investment in medical device research.