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FDA issues gender guidance in medical device testing

The FDA has waded into gender issues in studying the safety of medical devices.

The agency – which effectively deregulated consumer health devices and apps with draft guidance rules earlier this summer – now has issued draft guidance on using sex-specific data in medical device clinical studies, which remain heavily regulated.

The guidance makes specific recommendations for using gender during the clinical trial design stage to improve consistency of analysis and demographic reporting, according to an FDA advisory.

Among the recommendations to the medical device industry and FDA staff are: methods for designing and carrying out clinical studies to encourage enrollment of both men and women; methods for analyzing demographic data;  approaches for reporting demographic data in labeling and in public documents for approved devices; and decision frameworks for study design and accounting of sex-specific data when evaluating overall study outcomes, including when more data may be needed.

The 26-page measures set was accompanied by an action plan. Its introduction, written by FDA commissioner Margaret Hamburg, M.D., spells out the rationale for the new rules.

“When a more diverse population participates in clinical trials, we increase the potential to know more about the extent to which different subgroups — males and females, young and old, people of various racial and ethnic backgrounds, and patients with differing comorbid diseases and conditions – might respond to a medical product,” Hamburg writes. “And when subgroup data are analyzed, we have available more information about the product that can be communicated to the public. The result is greater assurance in the safety and effectiveness of the medical products used by a diverse population.”

As usual with draft guidance, the FDA notes that it is non-binding.

In reality, though, such moves usually carry the heft of the big regulatory agency, and in this case clearly signal that FDA officials felt that not enough importance was being given to gender in the medical device industry.

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