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FDA guidance: Designing clinical studies for PMA submissions

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FDA

The FDA took bold steps to outline expectations for medical device premarket submissions in the release of a new draft guidance that outlines the basic structure for clinical trials.

The document attempts to the foundational features of medical device trials, including what types of studies may be appropriate, how to avoid bias in subject or site selection and how to establish controls.

"We want to help manufacturers and researchers take the least burdensome approach to getting safe and effective products to market, Dr.  Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health, said in prepared remarks. "This guidance will help manufacturers and researchers better understand the FDA’s basic expectations for clinical trials."

While the guidance was designed primarily for devices undergoing PMAs, the recommendations may apply to 510(k) applications, according to a press release.

The new guidance allows CDRH to check off one more box on its 25-item Plan of Action for Implementation of 510(k) and Science Recommendations, a list of milestones and guidelines the agency hopes to reach this year to make the 510(k) process a "blueprint for smarter medical device oversight; one that drives innovation and brings important technologies to patients."

"Although the agency has articulated policies related to design of studies intended to support specific device types, and a general policy of tailoring the evidentiary burden to the regulatory requirement," according to the guidance, "the agency has not attempted to describe the different clinical study designs that may be appropriate to support a device premarket submission, or to define how a sponsor should decide which pivotal clinical study design should be used to support a submission for a particular device."

Until now, that is.

The new document delves deep into the clinical study process, addressing the use of random, consecutive or convenience selection in rounding up subjects to enroll in human trials, recommending that specific individuals be defined to evaluate study endpoints and devoting several paragraphs to describing the placebo effect and how to account for it.

The comment period is open for the next three months.

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