More Resources Sought For Using Patient-Preference Data In Device Reviews
This article was originally published in The Gray Sheet
Executive Summary
Some device user fee revenue could be used to enhance application of patient-preference data, FDA said at a recent meeting of patient and consumer groups about user-fee reauthorization. Several groups urged greater emphasis in that area at the closed-door meeting, and some groups also pushed for increasing device user fees closer to the much higher levels charged to drug firms.
You may also be interested in...
Industry Challenges FDA's User Fee Markup
During the first round of user fee negotiations, industry questioned FDA's estimated cost of $750 million needed to continue the device user fee program between 2018 and 2022. Lobby groups for the device industry continue to emphasize user fees should supplement congressional appropriations to pay for FDA's review of devices.
FDA Launches Patient Engagement Advisory Committee For Devices
FDA is seeking nominations for a new Patient Engagement Advisory Committee to help the agency’s device center understand patients’ experiences with medical technology and FDA communications and allow them more input to inform regulatory decisions.
Calls For More FDA Training In Lead Up To User-Fee Negotiations
Device firms will be pushing for more reviewer consistency and to avoid a major increase in fees during upcoming negotiations with FDA to reauthorize the Medical Device User Fee Act. The MDUFA IV reauthorization process starts as Congress is already considering major regulatory reforms and will finish under a new administration in the White House.