Federal Register Notice: FDA’s Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee will meet 5/13 from 8 a.m. to 5:30 p.m. at the Hilton Washington DC North/Gaithersburg, Salons A and B, 620 Perry Pkwy., Gaithersburg, MD. The committee will hear a presentation on FDA's Critical Path Initiative and a presentation by CDRH’s Office of Surveillance and Biometrics on their responsibility for reviewing postmarket study design. The committee will also discuss and make recommendations on general issues for pulse oximeters, such as equivalence of reflectance sensor technology to transmissive sensor technology; validation recommendations for neonatal intended use; and OTC use of pulse oximeters. Contact Neel Patel, (301) 443-8611, ext. 3. To view this notice, click here.
