March 2022

Pediatric Device Task Force 

Patrick Cahill, MD
Pediatric Device Task Force Chair

AAOS continues to lend resources and expertise to these efforts. We have held a series of calls with ADVAMED who support our aims. We seek allies in this effort and have held calls with AAP, CureSMA, AANS, and others

Based on the current political landscape, our expert advisors (AAOS advocacy staff, AAP advocacy staff, and ADVAMED strategists) feel that attempting to lobby congress to change FDA regulations to allow study groups to collect prospective data on off-label devices would be a reach.

Instead, we have adopted the aim of requesting congress to demand a study of current regulatory pathways for pediatric devices and the possibility of leveraging existing study groups as a means of collecting quality data for regulatory purposes. The task force adopted this aim on March 2, 2022. The goal is to have the study mandated as part of the renewal of Medical Device User Fee Amendments (MDUFA), the congressional action required to renew funding for the FDA.