The FDA may continue the Expedited Access Pathway Program (EAP). If this program is continued in the new administration, it represents an opportunity for innovative treatments that meet un-met medical needs. The program which started in 2014 allows for devices that are of reasonable risk to be marketed with post market testing. As part of the program a Data Development Plan must be prepared along with a characterization of the device as well as a Risk Analysis. The program is targeted for high risk conditions for which no therapy exists or is not available to a wide group of patients. So far the program is restricted to life threatening or debilitating conditions. If the program is continued it represents an opportunity for innovation and a streamlined approach to medical device clearances. It also offers an iterative approach to filings and FDA assistance and immediate feedback on clinical investigation strategies. Overall, the program, if continued in the new administration, represents an opportunity for innovators to take advantage of a streamlined pathway and put therapies into the hands of patients that need it most. The program has its limits such as the type of indications for entry and the use of the Pre-Submission process. For more information on the program, consult the FDA directly.
Cerneos will continue monitoring developments and keep our colleagues up to date on this program which we are continuing to use for our clients.