FDA Panel To Consider Data Shift For Pediatric Cochlear Implants
This article was originally published in The Gray Sheet
The Ear, Nose and Throat Devices Panel will convene for two days, April 30 and May 1, first to recommend risk-classification categories for five types of hearing devices and, on the second day, consider the potential of moving clinical requirements for cochlear implant modifications for kids to the postmarket phase.
You may also be interested in...
CDRH Director Jeffrey Shuren discussed the device center’s two-year strategic priorities with “The Gray Sheet.” The center plans to rebalance pre-market and post-market data collection, when appropriate, and improve the processes for starting up clinical trials in the U.S.
HAL Allergy Group, developer of products for allergy diagnostics and allergen immunotherapy, promoted its principal scientist to chief R&D officer; Starkey Hearing Technologies brought on new health and business development execs to expand its global footprint; and more.