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

The draft guidance clarifies that sex and gender are not interchangeable, but could be vulnerable in the Trump Administration as Republicans have argued against transgender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  • Before the FDA delves into the statistical issues with studying sex differences in clinical trials in a new draft guidance, it clarifies that it has not always used sex and gender language precisely and outlines upcoming changes.

A new US Food and Drug Administration draft guidance clarifies the difference between sex and...

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

More from Medtech Insight

Nyxoah Launches FDA-Cleared Genio System For OSA As Rival Inspire Files Patent Suit

 
• By 

After receiving FDA clearance for its Genio sleep apnea implant, Nyxoah plans a major US rollout despite a patent suit from rival Inspire Medical. Genio offers bilateral nerve stimulation as a CPAP alternative, with strong trial results.

Inaccurate Carbon Dioxide Readings Prompt Class I Recall Of Draeger Ventilation Filters

 

Draeger Medical has recalled certain SafeStar and TwinStar ventilation filters after reports of serious injuries caused by misleading carbon dioxide readings.

UK MHRA Ready To Evolve Approach To In-House Manufactured Medtech

 
• By 

The UK device regulator wants to align health institution device exemptions with its evolving policy of agile regulation of medtech in the British market. It asks stakeholders to complete a survey by Sept. 15.

FDA Panel Supports Dermal Fillers For Décolletage Use

 
• By 

An FDA panel has endorsed the use of dermal fillers for décolletage, but warned of patient safety concerns. The filler can cause complications with future imaging and pregnancy or breastfeeding, panelists said. Regulatory measures and patient studies are recommended for better outcomes.

More from Guidance

NHS Orders Halt On Unapproved AI Scribes, Vendors Rush To Self-Certify

 

NHS England's national chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.

FDA ‘Regulatory Accelerator’ Aims To Speed Digital Health Development

 
• By 

The US FDA has launched the Regulatory Accelerator to expedite digital health product development. This includes resources like a Resource Index for Innovators, a Medical Device Software Guidance Navigator, and best practices for early meetings.

Court Orders US FDA To Return Trial Diversity Action Plan Guidance To Website

 
• By 

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.