1. Medtech Insight

US FDA Attempts To Parse Sex Vs. Gender, But Will Politics Interfere?

 
• By Sarah Karlin-Smith

The draft guidance clarifies that sex and gender are not interchangeable, but could be vulnerable in the Trump Administration as Republicans have argued against transgender medical care and that sex and gender must be congruent.

Female and male sex symbols on pink and blue blocks
(Chawalit Banpot/Shutterstock)
Key Takeaways
  • Before the FDA delves into the statistical issues with studying sex differences in clinical trials in a new draft guidance, it clarifies that it has not always used sex and gender language precisely and outlines upcoming changes.
  • The guidance states that the terms sex and gender are not interchangeable.
  • The guidance may be controversial since Republicans have targeted transgender people on the basis that sex and gender should align.

A new US Food and Drug Administration

The guidance’s acknowledgement that sex and gender are not interchangeable, comes at a tense time in US political discourse about the issue

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Medtech Insight

SpotitEarly Raised $20.3M In New Funding To Bring AI- And Dog-Sniffing-Powered Early Cancer Detection Test To US

 
• By Marion Webb

Israeli-based SpotitEarly hopes to bring an early cancer-detection test, which uses dogs’ noses to detect compounds in exhaled breath and AI analysis, to US homes in 2026.

Thousands Of Cardiac Digital Twins Reveal Novel Connections With Mental Health

 
• By Natasha Barrow

King’s College London, Imperial College London and The Alan Turing Institute constructed cardiac digital twins at scale, creating over 3,400, in a new study using UK Biobank data published in Nature Cardiovascular Research on 16 May.

China Still ‘Attractive’ For Danaher Despite $50M VBP Drag

 
• By Shubham Singh

Apart from the reimbursement-driven turbulence in diagnostics, other aspects of Danaher’s China business are showing signs of resilience. Patient volumes remain strong and the company does not see evidence that the Chinese government is attempting to actively push Western suppliers out of its healthcare system.

Execs On The Move: 28 April - 2 May 2025

 
• By Medtech Insight Team

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.

More from Guidance

IMDRF Offers Granular Playbook On ‘Regulatory Reliance’ Program Development And Implementation

 
• By Elizabeth Orr

International device regulatory group IMDRF has issued a new playbook on “regulatory reliance,” which allows regulators to make use of assessments performed by trusted regulatory partners. The document is the first to offer a detailed guide on developing and implementing these agreements.

Global Medtech Guidance Tracker: March 2025

 
• By Vibha Sharma

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

HIMSS 2025: Interview with Aneesh Chopra, Arcadia’s Chief Strategy Officer, About The Future Of Health Data, Interoperability, AI

 
• By Marion Webb

Medtech Insight sat down with Arcadia's chief strategy officer Aneesh Chopra to discuss interoperability, industry standards and the future of health care data and AI.