Federal Register Notice: FDA’s Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee will meet 4/30-5/1 from 8 a.m. to 6 p.m. at the Hilton Washington DC North/Gaithersburg, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD. On 4/30 the committee will discuss and make recommendations on the classification of Hearing Protectors, Circumaural Hearing Protectors, Middle Ear Inflation Devices, Tactile Hearing Aid Devices, and Vestibular Analysis Apparatuses. These devices are considered preamendments devices since they were in commercial distribution prior to 5/28/76, when the Medical Devices Amendments became effective.
On 5/1 the committee will discuss key issues related to a potential pre- to post-market shift in clinical data requirements for modifications to cochlear implants in pediatric patients. Contact Patricio Garcia, (301) 796-6875 or Patricio.Garcia@fda.hhs.gov. To view this notice, click here.