IDE's - Early Feasibility Medical Device Clinical Studies and First In Human Studies
Today the Food and Drug Administration (FDA) released a final guidance document, Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.
The FDA recognizes the value of encouraging medical device innovation to address clinical needs and improve patient care, particularly when alternative treatments or assessments are unavailable, ineffective or associated with substantial risks to patient safety. This guidance provides new policies that enable device sponsors to move from bench testing to initial clinical studies more quickly, and speed the implementation of product or study design changes once a study begins, while still protecting human subjects.
This guidance outlines new policy regarding the application for and approval of early feasibility study IDEs. Two important elements of the guidance are:
- FDA is approval of an early feasibility study, including some first-in-human studies, may be based on less nonclinical data than would be expected for other types of studies (e.g., traditional feasibility or pivotal).
- The introduction of new approaches to facilitate timely device and clinical protocol modifications during an early feasibility study, while still maintaining compliance with FDA human subject protection requirements, including obtaining informed consent and Institutional Review Board (IRB) (or ethics committee) oversight.
The FDA is planning to hold an audio conference to further explain this guidance document on October 2, 2013 from 3:30 PM – 5:00 PM (EST). In order to participate in this conference, please call 888-469-0491 and input passcode: CDRH. In the event of a government shutdown, this audio conference will be cancelled and rescheduled for a later time.
Thank you for your continued support of the FDA and its mission.
Food and Drug Administration
Center for Devices and Radiological Health