The FDA last week announced a public meeting to be held in November by the Committee General and Plastic Surgery Devices Panel, to review numerous issues surrounding dermal fillers.
On November 18, 2008, the FDA will receive an update on safety information collected on dermal fillers in the commercial setting, discuss current premarket and postmarket approved study designs, and make recommendations on general issues concerning the study of various dermal fillers.
In addition, the committee will discuss the design of clinical trials for future premarket submissions seeking approval of dermal fillers for new intended uses.
On November 19, 2008, the committee will discuss and make recommendations on general issues related to the clinical trials of cosmetic devices. Specifically, the committee will make recommendations on how to quantify the effects of devices with various types of energy sources, such as light-based products, light-based combination devices, ultrasound devices (including focused ultrasound devices), massagers combined with other energy modalities, cryogenic energy devices, radiofrequency ablation devices, and microwave systems, on dermatologic conditions.
The meetings will be held at the Marriott Gaithersburg Washingtonian Center, Salons C and D, 9751 Washingtonian Blvd, Gaithersburg, Md. For more information, check out the Web site here.