FDA Guidances Will Seek to Foster Investigational Medical Device Studies

November 11, 2011—The US Food and Drug Administration (FDA) issued a draft guidance that is aimed at fostering early-stage development of medical devices within the United States, which the agency says will help to stimulate innovation and contribute to medical research.

According to the FDA, the guidance document contains new approaches to early feasibility studies and provides appropriate protections for human study subjects. The agency noted that such studies are necessary to resolve final design issues before the device is ready for a large clinical trial, as is typically required for product approval.

The draft guidance, "Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, including Certain First-in-Human Studies," applies to medical devices that are in the early stages of development to better inform the final design of the device. It would allow studies to start the device development process earlier than previously allowed and would permit select device modifications to be made without FDA approval.

The FDA also announced that it is seeking a small number of companies to pilot the new approaches described in the guidance. The results of the pilot program will help to inform the final guidance. Notice of the pilot program was published in the Federal Register.

According to the FDA, participation in the pilot program will be limited to nine sponsors. To qualify, sponsors should focus on innovative, early-stage development technologies that are most likely to benefit from the efficiencies of the program. Enrollment will begin on December 12, 2011. Enrollment will continue for 180 days from the November 10 publication of the Federal Register notice of the program or until a final guidance is published, whichever occurs first.

The FDA also issued a draft guidance regarding clinical trials and medical devices. The document describes the agency's process for approving applications from companies that wish to conduct clinical trials involving medical devices. The draft guidance, "FDA Decisions for Investigational Device Exemption Clinical Investigations," clarifies the FDA's process for approving clinical trials of medical devices. The document addresses when the FDA might allow patients to enroll in a study while issues are resolved (ie, approval with conditions). Such issues include data analysis methods that can be resolved prior to gathering the data or minor divergences from study endpoints or study design assumptions. The draft guidance also discusses when the FDA might allow studies to begin with a smaller group of subjects while companies gather additional data prior to the larger general enrollment (ie, staged approval).

"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," commented Jeffrey Shuren, MD, Director of the FDA's Center for Devices and Radiological Health. "Today's 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."