On November 19, 2008, the US Food and Drug Administration’s (FDA) General and Plastic Surgery Devices Panel (Panel) held a public meeting to discuss clinical data requirements for cosmetic devices that use low levels of energy for indications such as body contouring, skin tightening, acne, hair removal, and wrinkle reduction. Such devices utilize a broad range of energy sources, including electrical stimulation (TENS), light (laser/LED), ultrasound, radiofrequency, and microwave, and are generally cleared by FDA as Class II medical devices via the agency’s Premarket Notification (510(k)) clearance process. The Panel provided FDA with general recommendations on this topic, but did conduct an official vote on any of the issues discussed during the meeting.

The Panel discussed the types of clinical data that should be developed for cosmetic devices intended for non-therapeutic use. Panel members agreed that safety should be a primary clinical endpoint, but that patient satisfaction and quantitative measures should also be considered. FDA views quantitative measures as most feasible for indications like “thigh size” and “eyebrow lift,” which have treatment outcomes that are fairly easy to measure using imaging techniques, computed tomography, MRI, photography, etc.  Conversely, the use of quantitative measures for indications like body contouring, skin tightening and eyelid tightening would be less applicable due to the relatively small change produced as a result of treatment. The Panel further agreed that clinical data showing an improvement in functional or health outcome is not necessary for aesthetic indications unless functional or health outcome indications are proposed. Last, one Panel member noted that longer-term safety data and user training may be needed for devices with novel indications that are intended for use in non-clinical settings, such as spas. 

With regard to the extent to which the effects of treatment with a given device need to be understood, Panel members agreed 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. However, the Panel noted that, for devices with indications for temporary changes (e.g., “temporary change in the appearance of cellulite”) the duration should be specifically defined and demonstrated.  

The Panel meeting occurred at a time when FDA has received a growing number of 510(k) applications for devices intended for dermatological and aesthetic indications. To some extent, FDA may be in a quandary on how to evaluate certain device submissions. For example, FDA noted in its meeting outline that “validated or accepted measures of success do not yet exist for most of these indications.” FDA also noted that an increasing number of “dermatological energy disposition devices” are being promoted and marketed on the Internet for indications that “may or may not be clearly medical in nature,” such as “improves the appearance of the face” or “makes you look healthier.” Thus, where exactly do these types of products fit within FDA’s device hierarchy?

The Panel’s discussion on cosmetic devices provides FDA with general recommendations on data requirements to support 510(k) clearance. While it appears likely that patient satisfaction will continue to serve as a primary clinical endpoint for cosmetic devices indicated for non-therapeutic use, factors like novel indications, mode of action, energy output levels, use-parameters, and safety considerations will also influence the data requirements imposed on each 510(k) application.

We continue to follow this issue and provide updates when available. Please let us know if you have any questions.

Georgia Ravitz
ravitz.georgia@arentfox.com
202.857.8939

James R. Ravitz
ravitz.james@arentfox.com
202.857.8903

James H. Hartten
hartten.james@arenfox.com
202.857.8983

Amy S. Colvin
colvin.amy@arentfox.com
202.857.6338