MASSDEVICE ON CALL — Based on the results of a newly unveiled study, the FDA plans to implement new processes to ensure that women make up an appropriate portion of medical device post-approval studies.
Nearly half of the premarket approvals and humanitarian device exemptions handed out since 1991 have included post-approval approval requirements, and sex-based data is available for more than 90% of them, according to the study authors. The reports show that women frequently make up less than half of the patients population in cardiovascular, orthopedic, and renal/urologic studies.
"Data on age and race by sex was limited in the submitted reports and not routinely assessed in FDA reviews. Data on other demographic characteristics are needed as prevalence of disease varies by age, sex, and race," the authors wrote. "These factors are important in assessing if participation is representative of the intended population. Both the applicant and FDA should make additional efforts to ensure data on demographic characteristics are reported and assessed in a meaningful manner."
Insufficient female representation in medical testing has come up before, especially with regard to cardiovascular devices. The FDA in December 2011 issued draft guidance designed to increase the number of female subjects enrolled in med-tech clinical trials, and the agency just last month published a blog about its efforts in highlighting women’s needs in medical device design considerations.
The FDA has been workshopping a new program that it calls HoW, or Health of Women, which is focused on looking more closely at medical device use in women.
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