Federal Register Notice: FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee will meet 6/8, from 9 a.m. to 5 p.m. The committee will hear a presentation on the FDA Critical Path Initiative and a presentation by CDRH’s Office of Surveillance and Biometrics outlining its responsibility for reviewing postmarket study design. The committee will also discuss general issues on premarket requirements for the safe and effective use of hemodialysis equipment labeled for nocturnal hemodialysis therapies. The meeting will take place at Holiday Inn, Walker/Whetstone Rooms, Two Montgomery Village Ave., Gaithersburg, MD. Contact Jeffrey Cooper, (301) 594-1220, ext. 121. To view this notice, click here.
