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FDA releases blueprint for improving clinical trial design, device applications

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Jeffrey Shuren

SILVER SPRING, Md. — The U.S. Food and Drug Administration has issued a draft guidance document to assist researchers and manufacturers in improving the design of clinical trials undertaken to support premarket approval applications for medical devices, the agency announced in a news release.

Manufacturers submit premarket approval applications (PMAs) for high-risk medical devices. PMAs include data from pivotal clinical trials that the FDA uses in conjunction with other salient information in considering approval.

The guidelines are among 25 action items included in a Plan of Action for Implementation of 510(k) Approval and Science recommendations the FDA issued earlier this year to enhance the predictability and transparency of regulatory channels and to strengthen the 510(k) process, the release said.

"We want to help manufacturers and researchers take the least burdensome approach to getting safe and effective products to market," Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, said in the release. "This guidance will help manufacturers and researchers better understand the FDA's basic expectations for clinical trials. We encourage researchers to contact the FDA to discuss the most practical approach to studying their device."

The guidelines address minimizing data bias and variability, setting appropriate study objectives, selecting the appropriate type of study, and choosing study sites and study participants, the release said.

The FDA will accept comments on the guidelines within 90 days of publication in the Federal Register. Written comments may be mailed to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Comments may be sent electronically to http://www.regulations.gov. All comments should be accompanied by the docket number listed in the notice of availability published in the Federal Register.

For more information about the guidelines, go to http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm265553.htm.