On October 7, 2011, the Centers for Medicare & Medicaid Services and the Food and Drug Administration announced they are soliciting nominations from sponsors of medical devices to participate in a parallel review pilot program. The Agencies officially published a Federal Register notice announcing the program October 11, 2011 (the “Notice”), with an effective date of November 10, 2011, although the agencies began accepting nomination submissions October 7.  Notably, drugs and biological manufacturers are not included in this pilot program, although the agencies state that they intend to use their experience with the medical device pilot program to expand the program to include drugs and biological products in the future. The Notice outlines the procedures for participation in the pilot program, emphasizes the voluntary nature of the pilot program, discusses the appropriate candidates for the pilot program, and conveys the “guiding principles” the agencies plan to follow in implementing the pilot program. The agencies intend to run the pilot program for two years, with the possibility of an extension beyond the two-year program or termination prior to the end of the two-year program. Because of constrained resources, the agencies plan to accept only three to five nominations for parallel review per year. Reed Smith’s Alert summarizes the Notice and discusses potential implications for manufacturers that may be considering participation in the pilot program.