FDA accepts 17, rejects 12 in first year of medical device Expedited Access Pathway

The FDA has made 29 decisions under its new Expedited Access Pathway Program for Medical Devices in its first year, the agency noted in a recent blog post. Of these, 17 were accepted with the remainder denied. These decisions were usually made in 30 days. The program is intended to facilitate faster access to novel technology for patients with serious diseases and unmet need. Products under the EAP program ultimately either go through Premarket Approval (PMA) or de novo review. "As the program has grown in the past year, we've  learned that companies who benefit most from this program are those that have a preliminary proof of principle for how their device works, but haven't undertaken formal studies to support future submissions to FDA. For these companies, discussing their Data Development Plan with the FDA and agreeing on a roadmap to their marketing application and beyond is an important part of a successful review," said Erin Cutts of the Office of Device Evaluation in FDA's Center for Devices and Radiological Health. More