The U.S. Food and Drug Administration is seeking to offer clarity to manufacturers and reviewers of medical devices. On Monday, the agency released proposed guidance on how benefit-risk determinations are made during premarket review and how researchers and manufacturers can design better quality clinical studies in support of premarket approval applications (PMAs) of medical devices.
The FDA’s proposed guidelines clarify how benefit-risk determinations for high-risk medical devices are made. “FDA believes that the uniform application of the factors listed in this guidance document will improve the predictability, consistency and transparency of the premarket review process,” the agency notes in the introduction to the proposed guidance.
“As medical devices grow increasingly complex, many factors impact our benefit-risk determinations, especially for PMA devices,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health in a statement accompanying the proposed guidance. “This guidance aims to provide more clarity to manufacturers about what factors we consider when making an approval decision.”
[See also: FDA should replace medical devices clearance program.]
As part of the guidance, the FDA also recommends that medical device reviewers use a worksheet it has created to document how they make benefit-risk determinations. Some of those worksheets, the FDA says, may be made public after a device is approved.
In its introduction of its proposed guidance for high-quality clinical studies of PMAs for medical devices, the agency noted that while it has articulated policies about the design of clinical studies of medical devices in the past, it has not defined or described the various designs such studies may take.
The FDA’s proposed guidance for clinical studies of PMAs for medical devices outlines its “expectations for clinical trial design issues such as minimizing data bias and variability, setting appropriate study objectives, selecting the appropriate type of study and choosing study sites and study participants.”
“We want to help manufacturers and researchers take the least burdensome approach to getting safe and effective products to market,” Shuren said in a statement. “This guidance will help manufacturers and researchers better understand the FDA’s basic expectations for clinical trials.”
Both guidance drafts are open for public comment within 90 days of posting in the Federal Register.