1. Medtech Insight
  2. >>ESG

Diversity Action Plans Should Be Brief And Waiver Requests Filed Early, US FDA Says

 
• By Sue Sutter and Ryan Nelson

In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.

Diverse hands
The FDA expects studies can be conducted with diversity action plans 'in most cases.' • Source: Shutterstock

The US Food and Drug Administration wants new clinical trial diversity action plans to be short and waiver requests filed early, albeit with little expectation that they will be granted.

In addition, the agency’s push for sponsors to publicly disclose details about their diversity action plan (DAP) and enrollment goals may

Key Takeaways

  • Diversity action plans should be succinct, running no more than 10 pages.

  • Waiver requests need to be filed early so there is time to submit a DAP if the waiver is denied

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 Diversity & Inclusion

FDA Scrubs ‘Gender’ From Final Guidance On Sex-Specific Data But Encourages More Women In Clinical Trials

 
• By Brian Bossetta

The US FDA has published its final document to guide sponsors on using sex-specific data in designing clinical trials of medical devices. However, the guidance removes all references to gender that appeared in January’s draft guidance, released before the Trump administration took office.

Drop Email Pronouns And Return To Work, Administration Orders FDA Staffers

 
• By Brian Bossetta

Chaos continues at the FDA’s device center as reinstated staffers begin daily commutes to comply with the administration’s return to office policy. Staffers can no longer publicly share their pronouns per Trump’s “Defending Women” executive order.

Brooklyn Medtech Works To Bring Hospital-Level Care To Remote Areas

 
• By Elizabeth Orr

10XBeta is helping to develop a modular mobile health care platform as part of a federal initiative to improve the quality of care in rural areas. Company CEO Marcel Botha told Medtech Insight that the product fits the company’s goals of bringing treatment to the people who need it most.

AI Bias Page, Health Equity Discussion Paper Back On FDA Site

 
• By Elizabeth Orr and Sue Sutter

Two US FDA device center websites have been restored under a restraining order. The pages now carry a disclaimer alleging they include "extremely inaccurate" content about gender; however, neither site includes any substantive discussion of trans issues.

More from ESG

ARPA-H Announces Grants To Advance Rural Care

 
• By Elizabeth Orr

The 12 initial awards, which total almost $100m, are part of an ongoing program to develop a high-tech mobile hospital that can reach patients with limited access to health care.

EU Public-Private Partnership Invests €66.8M To ‘Transform Clinical Studies’ By Boosting Diversity

 
• By Anabel Costa-Ferreira

A six-year project aiming to establish a “less fragmented and more democratic” approach to clinical studies has commenced in the EU.

Are Downed DEI Pages Part Of Trump Executive Order Sweep, Or Just The Result Of Routine Transition?

 
• By Brian Bossetta

Several pages on the US FDA website related to diversity and inclusion are down, which aligns with Trump’s recent executive order on diversity, equity, and inclusion. However, the Department of Health says there's been a “short pause” in communications to allow the incoming team to get in place.