1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Regulation

CDRH Launches Patients’ Preference Project

Associate director for science at FDA’s device center highlights ongoing efforts to incorporate more quantitative patient input in device reviews.

The recent FDA user fee law for device makers includes provisions to help incorporate wider stakeholder input in agency decision-making, which should help reinforce CDRH’s recent efforts to gather more substantive views from patients on the risk-benefit trade-offs of medical devices, an agency official said recently.

“We don’t want to just listen to patients and have a non-quantitative way of making sure we incorporate their views,”...

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 Regulation

EU Medtech Regulations: Key Updates Ahead of December Proposal

While anticipation grows around the European Commission’s forthcoming medtech proposal, due in mid-December, a series of EU documents have been published on topics including recertification, standards, changes to companion diagnostics and the latest notified body announcements.

What Do Money, Gender, And Politics Have To Do With Device Recalls? Quite A Lot

 
• By Brian Bossetta

During the MDIC Excellence in Quality Summit, an expert in product recalls offered several unconventional and somewhat controversial factors that impact how quickly device makers initiate a recall once they discover a problem.

Can Chatbots Treat Depression? FDA Advisers Urge Caution on Generative AI Tools

 
• By Elizabeth Orr

FDA advisers gave a cautious nod to the idea of using generative AI in mental healthcare during a Nov. 6 panel meeting, saying evidence-backed tools could help expand access – but warning that safety, oversight, and the irreplaceable human connection remain major unanswered questions.

Under Pressure: How To Safeguard The EU Responsible Person

 
• By Amanda Maxwell

The roles and responsibilities of EU medtech’s persons responsible for regulatory compliance vary widely in role and risk exposure. The recent TEAM-PRRC meeting highlighted how vulnerable they can be and the steps to protect themselves.

More from Policy & Regulation

Can Chatbots Treat Depression? FDA Advisers Urge Caution on Generative AI Tools

 
• By Elizabeth Orr

FDA advisers gave a cautious nod to the idea of using generative AI in mental healthcare during a Nov. 6 panel meeting, saying evidence-backed tools could help expand access – but warning that safety, oversight, and the irreplaceable human connection remain major unanswered questions.

Makary And Oz Tout Successes At Their Respective Agencies, Say They Are Breaking Down Walls

 
• By Brian Bossetta

Nearly one year into leading their agencies, US FDA Commission Marty Makary and CMS Administrator Mehmet Oz took to the stage together at the Milken Institute’s Future of Health Summit 2025 to highlight what they see as progress and lay out plans for the road ahead.

Global Medtech Guidance Tracker: October 2025

 
• By Vibha Sharma

Stay current on regulatory guidelines from around the world with Medtech Insight’s Guidance Tracker. Over 60 documents have been posted on the tracker since its last update.