November 18, 2008
The General and Plastic Surgery Devices Panel (the Panel) met on Tuesday, November 18, 2008, at the Marriott Gaithersburg Washingtonian Center located at 9751 Washingtonian Boulevard in Gaithersburg, Maryland. The Panel met in order to 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 Panel met to discuss the design of clinical trials for future premarket submissions seeking approval of dermal fillers for new intended uses.
The meeting began with an open public hearing session and a brief update from FDA to the panel, followed by presentations from FDA. The presentations focused on a postmarket analysis of adverse events reported to FDA, the postapproval study results for dermal filler use in subjects with Fitzpatrick skin types IV – VI, a review of the current premarket study designs, and the clinical study considerations for potential new indications for use.
The Panel discussed and commented on FDA questions related to the listing of adverse event information in the labeling, effective methods for FDA to communicate postmarket information to physicians, and design considerations for pre- and postmarket studies of dermal fillers with the current indications, as well as, with potential new indications. The Panel generally believed that the product labeling should be updated to include current information on adverse events including safety information obtained from postmarket studies and through postmarket adverse event reporting. The Panel recommended that the postmarket safety information should be widely disseminated not only to physicians but also to consumers, through labeling, websites, training materials and physician organizations. Regarding the evaluation of fillers in patients with Fitzpatrick IV – VI skin types, the Panel believed that FDA should continue to collect safety information on these patients and that this information should be obtained premarket. In addition, the Panel provided the following specific advice regarding pre- and postmarket study designs. The Panel believes that the current methods to evaluate device effectiveness are adequate for current indications, but not for new indications. While patient satisfaction measures are important, it is also important to obtain objective measures of effectiveness. Functional assessments should be included in studies of filler use in other anatomical locations. Larger studies should be designed with durations that exceed the expected duration of the product.
November 19, 2008
The General and Plastic Surgery Devices Panel (the Panel) met on Wednesday, November 19, 2008, at the Marriott Gaithersburg Washingtonian Center located at 9751 Washingtonian Boulevard in Gaithersburg, Maryland. The Panel met in order to discuss and make recommendations on general issues related to the clinical trials of aesthetic (cosmetic) devices. Specifically, the panel made 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, intended for use for dermatologic conditions or aesthetic (cosmetic) use.
The meeting began with an open public hearing session followed by the presentation from FDA. The presentation focused on current and new dermatologic and aesthetic indications for devices with various types of energy sources, and current methods of clinical effectiveness evaluation.
The Panel discussed and commented on FDA questions related to acceptable clinical endpoints for devices that are not intended for therapeutic uses. The Panel generally believes that, while safety is the primary concern for these devices, with regard to effectiveness, both patient satisfaction measures and objective measures are necessary. The Panel also believes that an improvement in functional or health outcome is not necessary for aesthetic indications unless functional or health outcome indications are proposed. With regard to understanding the effects of the treatment, the Panel believes that a general understanding of the expected extent of the intended effect is adequate and that demonstration of a fixed effect that is predictable for all patients is not necessary. Lastly, the Panel recommended that, for devices with indications for temporary changes, the duration should be specifically defined and demonstrated.
Contact: Lisa M. Lim, Ph.D., Executive Secretary, at 240-276-3555 or email@example.com.
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