1. Medtech Insight

Balancing Diversity and Effectiveness: Industry Feedback on FDA’s DAP Guidance

 
• By Elizabeth Orr

The medical device industry supports the FDA's draft guidance document on Diversity Action Plans but seeks flexibility and clarity, especially for international and IVD trials, and recommends using real-world data for postmarket studies.

Photo illustration demonstrating competing interests balancing on a scale.
(SvetaZi /Shutterstock)

The US Food and Drug Administration’s final guidance document on Diversity Action Plans (DAPs) should carve out devices that are equally effective across demographics, trade group the Medical Device Manufacturers Association said in a recent public comment.

The comment was one of about 140 submitted in response to June’s draft guidance document on improving enrollment of...

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

Zimmer Biomet Targets 2027 Launch For Semi-Autonomous Orthopedic Robot After Monogram Acquisition

 
• By Shubham Singh

Zimmer Biomet expects the Monogram deal to meet its financial and strategic criteria, be neutral to adjusted earnings per share from 2025 through 2027 and become accretive thereafter.

Survey Reveals Gaps In Medtech Compliance Processes

 
• By Elizabeth Orr

Medical device firms often have serious compliance gaps, a recent Veeva MedTech survey found. Only 50% of the companies surveyed are confident in their global registration data, with 70% reporting inconsistencies during audits. The report recommends automation and better data governance.

Environmental Group Questions FDA’s Stance On PFAS In Medical Devices

 
• By Brian Bossetta

The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.

EU4Health Boost For Orphan Devices And SMEs

 
• By Ashley Yeo

EU4Health, the main funding instrument for EU health initiatives, has put renewed emphasis on orphan devices in its 2025 work program, published in July.

More from Business

Additional Death And Injuries Added To 2024 Philips Ventilator Recall

 
• By Brian Bossetta

Philips Respironics has updated instructions for use for three ventilators that were included in a May 2024 recall. The company also added three potential injuries and one death to the original number.

Ultromics Wins $55M, The Key To Success: Diagnosing Diseases With Available Treatment

 
• By Natasha Barrow

Ultromics has secured $55m in Series C funding to advance its AI tool, EchoGo, which detects undiagnosed heart failure. The company's focus on diseases with available treatments resonated with investors.

Stryker Revises FY25 Tariff Estimate To $175M From $200M As EU Trade Pressures Mount

 
• By Shubham Singh

Kevin Lobo, chairman and CEO of Stryker said that the company is not as exposed to China as others and has manufacturing operations in Europe, influencing the overall tariff impact.