The US Food and Drug Administration has published new information online explaining how medical device manufacturers may apply and qualify for limited-scope clinical investigations known as Early Feasibility Studies (EFS).
The new FDA webpage explains that EFS targets manufacturers of novel or innovative devices in the early stages of development; these devices have little to no prior clinical and/or non-clinical data available, so data and experience obtained from an EFS may help sponsors and FDA reviewers assess device design concepts as well as clinical safety and performance issues on such products.
First outlined in 2013 FDA guidance, the EFS program features interactive reviews involving manufacturers, regulatory staff and clinicians, as well as program application and submission assistance from FDA staff. The program requires less non-clinical data from manufacturers than the standard Investigational Device Exemption (IDE) route, and is intended to allow speedier modifications to devices and clinical protocols.
The FDA’s EFS program is open to medical devices that require 510(k) premarket notification, Premarket Approval (PMA), De Novo classification and Humanitarian Device Exemption (HDE) reviews.
“EDS may be applicable when clinical experience is necessary because non-clinical testing is unavailable or inadequate to provide the information needed to advance device development,” states the FDA’s EFS webpage.
Examples of devices that may qualify for EFS include:
The FDA has established a four-step process whereby medical device manufacturers may apply for participation in the EFS program: