Federal Register Notice: FDA’s Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will meet 7/10-11 from 8 a.m. to 6 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will discuss the safety of laparoscopic power morcellator devices as it pertains to their potential to disseminate and upstage a confined, but undetected (occult) uterine malignancy during laparoscopic hysterectomy or myomectomy. FDA is seeking expert scientific and clinical opinion on the risks and benefits of these types of devices when used for these procedures, based on available scientific data. The committee will make recommendations on the appropriate use, premarket testing, labeling, and other risk mitigations (including the use of containment bags) for these devices.
On 7/11, during the afternoon session, the committee will also be asked to discuss the regulatory classification of laparoscopic power morcellator devices when used to cut and extract tissue during gynecologic laparoscopic procedures and to assist FDA in determining the appropriate level of regulatory control necessary for this device type, including discussion of Class 2 (special controls) or reclassification to Class 3 (subject to PMA). Contact Shanika Craig, (301) 796-6639. To view this notice, click here.