FDA issues draft guidance on medical devices, launching pilot program with nine companies
The FDA has issued two draft guidance documents that focus on early-stage development of medical devices.
“Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, including First in Human (FIH) Studies,” out earlier this month, applies to medical devices in the early stages of development. The goal: to better inform the final design of the device.
The DA said the new rules would permit studies to start earlier in the device-development process than previously allowed. They also would allow select device modifications to be made without FDA approval.
To test out the potential new regulations, the FDA said it is seeking nine companies that could pilot the new approaches, with the results helping inform the final guidance. To qualify, sponsors must focus on innovative, early-stage development technologies most likely to benefit from the program. The FDA said enrollment will begin Dec. 12.
“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,” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a press release.
However, AdvaMed is taking a wait and see approach to the new documents. The large trade association represents medical device manufacturers, makers of medical equipment, software and supplies, and medical technology innovators.
“We will be looking to see if the FDA proposals will improve the efficiency, timeliness and predictability of the IDE process, which has experienced a steady deterioration in performance in recent years,” the group told CenterWatch. “According to FDA’s own data, the percent of IDEs approved on the first review cycle declined 26% from FY 2000 to FY 2009 (76% vs. 56%); the percentage declined another 43% in FY 2010 (56% vs. 32%).”
The second draft guidance, “FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations,” seeks to clarify the agency’s process for approving applications from companies that want to conduct clinical trials on medical devices.
Before investigators can proceed with a clinical study involving a medical device that poses significant risks to human subjects, the FDA must approve an IDE. Such approval allows a medical device to be studied on subjects who consent to being part of the investigation. The new guidance touches on two key points:
When the FDA might allow patients to enroll in a study while issues are resolved, an approach called “approval with conditions.” Appropriate issues might include data analysis methods that can be resolved prior to gathering the data or minor divergences from study endpoints or study design assumptions.
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, an approach called “staged approval.”
“[The] guidance documents give sponsors and FDA device reviewers more flexibility to start investigational studies sooner while maintaining appropriate human subject protections,” said Shuren, “and they propose efficient ways to support product or study design changes once the study begins.”