Cosmetic Medical Devices and Their FDA Regulation

Cosmetic Devices Based on Active Transdermal Technologies

“…Many of the cosmetic devices marketed in USA are class I devices that do not need pre-market approval from the FDA or class II devices that are cleared by the 510(k) application, where the 'safety and efficacy' of these devices are compared with that of a 'substantially equivalent' commercially available cosmetic device [6,13]. Most cosmetic devices are listed as class II devices; in particular lasers, intense pulsed light (IPL) devices, radiofrequency devices and ultrasound devices that provide deep-tissue healing [13].…”

“…Most cosmetic devices are listed as class II devices; in particular lasers, intense pulsed light (IPL) devices, radiofrequency devices and ultrasound devices that provide deep-tissue healing [13]. Table 2 gives a summary of several cosmetic devices available on the market that incorporate the active transdermal technologies discussed in this article.…”

Demystifying the U.S. Food and Drug Administration

“…In these circumstances, it is crucial that patients be educated when this is the case. 23 With regard to biologics designed for very specific applications, another way that the U.S. Food and Drug Administration may ensure the safety of high-risk devices or biologics is to require training of practitioners or to specify how a product may be marketed by manufacturers. We see this in the case of Xiaflex (Auxilium Pharmaceuticals, Inc., Chesterbrook, Pa.), a collagenase used to treat Dupuytren's contracture.…”

“I enjoyed your talk, but…”: Evidence-based medicine and the scientific foundation of the American Venous Forum

“…Class I devices require only general controls such as good manufacturing practices and quality regulation; class II devices require special controls such as performance standards, registries, and/or post marketing surveillance; while class III devices require more extensive study due to a potentially increased risk of illness or injury. 7,8 New devices are generally class II or class III and are brought to market through either a Premarket Notification (510 (k)) or Premarket Approval (PMA) application. Although the PMA process is more rigorous and requires clinical trials in humans, over 90% of new devices belong to class II and are approved through the 510 (k) process, largely requiring demonstration that the safety and effectiveness are substantially equivalent to a marketed predicate device.…”

“…Although the PMA process is more rigorous and requires clinical trials in humans, over 90% of new devices belong to class II and are approved through the 510 (k) process, largely requiring demonstration that the safety and effectiveness are substantially equivalent to a marketed predicate device. 7,8 Unfortunately, although this process is effective in encouraging the development of new technology and does provide some mechanism for insuring safety, it often sheds little light on effectiveness with respect to clinically relevant outcome measures.…”