FDA Finally Asks: Do Medical Devices Actually Work for Women?
Published Date: 1/7/2025
Notice
Summary
The FDA just shared a draft guide to help medical device makers study how devices work differently for people of different sexes and genders. This means companies will need to think carefully about sex and gender when testing devices to make sure they’re safe and effective for everyone. Comments on this draft are open until April 7, 2025, so get your thoughts in before then!
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Sponsors Must Consider Sex & Gender
If you make medical devices, the FDA issued a draft guidance that asks sponsors to consider sex and/or gender when designing clinical studies and when reporting study data. The draft gives updated recommendations for study design, participant enrollment, data collection, analysis, and reporting, and it is open for comment through April 7, 2025; the document is not final and is not for implementation now.
Better Representation in Device Studies
The draft guidance encourages that medical device studies include participants who represent the intended population, including females, people with intersex traits, and people with transgender or nonbinary gender identities. You may see future device studies and reporting place more emphasis on sex- and gender-specific data so that benefits and risks are better understood for those groups.
No New Paperwork Burden
The FDA states this draft guidance contains no new collection of information under the Paperwork Reduction Act. The guidance references previously approved OMB collections such as control numbers 0910-0120, 0910-0231, 0910-0078, and others.
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