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.
