The U.S. Food and Drug Administration issued a draft guidance aimed at fostering early-stage development of medical devices within the United States that contains new approaches towards early feasibility studies in which a small number of patients get to undergo treatment with early device development conducted with appropriate human protection. To help promoting U.S.-based innovation and contribute to medical research doing early-stage development is important.
These early-stage development studies are essential to solve final design issues prior to starting large clinical trials that are generally required to get products approved. The FDA is looking for a few companies that could pilot the new guidance approaches to assist them in obtaining information for the final guidance.
The FDA also issued guidance about clinical trials and medical devices, describing the FDA’s approval process for applications from companies that want to conduct clinical trials involving medical devices.
Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health explained: “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. 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.”
Before clinical studies involving medical devices that pose significant risks to humans can proceed, they must first submit an application to the FDA for approval of an Investigational Device Exemption (IDE), which allows medical devices to be studied on humans who consent to being part of the investigation.
The FDA process for the approval of clinical trials of medical devices is clarified in the draft guidance “”FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations”. In includes an “approval with conditions”, which means that the FDA might permit the enrollment of patients in studies whilst issues are being resolved. These might include data analysis methods that can be resolved before gathering the data, or minor divergences from study endpoints or study design assumptions.
It may also issue a “staged approval” which means that the FDA might allow studies to start with a smaller group of subjects whilst companies gather additional data before the larger general enrollment of subjects.
For medical devices in the early stages of development, to gain better information on the final device design, the FDA has designed the draft guidance “Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, including First in Human (FIH) Studies”. This allows an earlier commencement of studies in the development process than previously and also permits that select device modifications can be made without FDA approval. The Federal Register announced that participation in the pilot will be limited to nine sponsors who should focus on innovative, early-stage development technologies in order to qualify, which are most likely to benefit from the program’s guidance.
Enrollment will commence Dec. 12, 2011 for a period of 180 days either from November 10, or until a final guidance is published, whatever date occurs first.
Written by: Petra Rattue