Survey on Increasing Pediatric Devices

Federal Register notice: FDA is reinstating an information collection entitled “Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation (CERSI) B12 Pediatric Device Survey.” The survey collection supports FDA’s interests and efforts to increase the number of devices approved for use in pediatric patients. The agency is concerned that too often current devices are adapted for use in children without an appropriate level of evidence, exposing them to inconsistent benefit/risk profiles. To address the challenges, the collection is being done to survey industry and other key stakeholders in the medical device ecosystem to identify the barriers that prevent product developers from entering the pediatric device market as well as to assess the proper incentives that would motivate them to innovate and sustain within this market. To view the notice, click here.