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Medical devices often approved for use without testing for safety by sex and gender

July 26, 2017

A new study finds that before the government approves medical devices for use on the public, companies applying for approval rarely determine if or how sex and gender might influence their safety or effectiveness.

“We are learning so much about how sex and gender play a role in the development of diseases, conditions, and their treatments,” said Women’s Health Research at Yale Director Carolyn M. Mazure, Ph.D., a co-author on the study. “It is time that we apply the same scrutiny to medical devices to ensure that they are safe and effective for all.”

Dr. Sanket S. Dhruva, a Clinical Instructor in Cardiology at Yale School of Medicine, was the lead author of the study, published Monday in JAMA Internal Medicine. Dr. Rita F. Redberg of University of California, San Francisco, also contributed.

The researchers examined 82 studies filed in 2015 with the U.S. Food and Drug Administration (FDA) in support of premarket approval for original medical devices. Of the 77 studies that included both men and women, only 17% were analyzed by sex. Only 9% were analyzed by age and 4% by race.

The researchers found infrequent analyses despite an action plan implemented by the FDA in 2014 calling for examination of results by age, race, and/or ethnicity.

It is time that we apply the same scrutiny to medical devices to ensure that they are safe and effective for all.

Dr. Carolyn M. Mazure

The study arrives in advance of Congress’ consideration to reauthorize the Medical Device User Fee Amendments by Sept. 30. Reauthorization of the amendments, first established by a law in 2002, provides the opportunity for Congress to require the clinical trial enrollment of women, minorities, and the elderly in the proportions used by device’s target population.

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Submitted by Carissa R Violante on July 26, 2017