FDA issues two draft guidance documents to facilitate investigational medical device studies in humans


The US Food and Drug Administration FDA has issued a draft guidance aimed at fostering early-stage development of medical devices within the United States.

The guidance document contains new approaches towards early feasibility studies, which are conducted in a small number of patients early in device development, while providing appropriate human subject protections. Such studies are necessary to resolve final design issues before the device is ready for a large clinical trial that is typically required for product approval. The FDA is seeking a small number of companies that could pilot the new approaches in the guidance. The results of the pilot will help to inform the final guidance.


The FDA has also issued another guidance regarding clinical trials and medical devices. It describes the FDA’s process for approving applications from companies that want to conduct clinical trials involving medical devices.
“Approaches to regulation that facilitate early clinical experience with investigational medical devices can result in safe and effective devices that reach patients sooner and create incentives to innovate in the United States,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “The guidance documents give sponsors and FDA device reviewers more flexibility to start investigational studies sooner while maintaining appropriate human subject protections, and they propose efficient ways to support product or study design changes once the study begins.”


Before investigators can proceed with a clinical study involving a medical device that poses significant risks to human subjects, the FDA must approve an Investigational Device Exemption (IDE). IDE approval allows a medical device to be studied on subjects who consent to being part of the investigation. 


The draft guidance “Investigational Device Exemptions (IDE) for early feasibility medical device clinical studies, including first in human (FIH) studies” applies to medical devices in the early stages of development to better inform the final design of the device. It would allow studies to start earlier in the device development process than previously allowed. It would also permit for select device modifications to be made without FDA approval.


Participation in the pilot will be limited to nine sponsors.To qualify they should focus on innovative, early-stage development technologies that are most likely to benefit from the efficiencies of the programme. Enrolment will begin on 12 December 2011 and continue for 180 days from the Federal Register notice or until a final guidance is published, whichever occurs first.