The FDA has released two new draft guidance documents aimed at establishing earlier clinical studies during device development while also clarifying the agency’s process for approving clinical trials.
In coordination with one of the documents, issued Nov. 10, the FDA is currently seeking a small number of companies to participate in a pilot program to help inform the final guidance on early feasibility studies.
“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 Jeffery Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, in a statement. “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.”
Currently, device manufacturers must receive an Investigation Device Exemption approval before they can proceed with a clinical study that involves a product which poses significant risks to human subjects. After approval, consenting subjects can participate in a study. In the second draft guidance released, the FDA describes the process for conditionally approving studies, and offers charts noting factors which contribute to their decisions.
Among the clarifications are descriptions of when the administration might allow patients to enroll in a study while device issues are still being resolved, and when they might allow studies to begin with smaller groups of subjects while companies gather additional data.
The full FDA drafts guidance documents can be found here: “FDA Decisions for Investigation Device Exemption Clinical Investigations”
and “Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies.”
The FDA limited the pilot for early feasibility studies to nine companies, and qualification to participate will include innovative, early-stage development technologies that are likely to benefit from it. Enrollment will begin on Dec. 12, and continue for 180 days as of Nov. 10.
Click here for more information about the pilot program.