1. Medtech Insight

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,” said Michelle McMurry-Heath, CDRH associate director for science, at a Sept. 20 user fee meeting in Washington, D.C

More from Regulation

More from Policy & Regulation

Health Secretary Defends Spending Cuts During Senate Hearing On HHS Budget

 
• By Elizabeth Orr

Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.

Tariffs Threaten Medtech Innovation And US Position As World Leader, Whitaker Tells Lawmakers

 
• By Brian Bossetta

During his testimony before US senators on the impact of tariffs on critical supply chains, AdvaMed’s Scott Whitaker said the Trump tariffs could jeopardize America’s preeminence in medtech. Other industry experts echoed similar concerns.

Califf Warns Progress May Be In Danger Due To ‘Decimated’ FDA Staff

 
• By Barnaby Pickering

In Vivo spoke to the previous commissioner of the US FDA about recent ongoings at the agency, and where he believes policy should be directed for patient and industry benefit.