FDA Explains PMA Rules for Dermatology Devices

Three CDRH staff members are using a JAMA Dermatology editorial to give dermatologists an understanding of each of the different types of PMA (premarket approval) applications for new and modified Class 3 medical devices affecting dermatology. The article notes that with the increased awareness of skin conditions and demand for aesthetic treatments requiring the expertise of dermatologists, there has been a growth in the associated medical device industry. Dermatology medical devices include point-of-care diagnostics, ablative technologies, skin imaging devices, dermal fillers, lasers, and wound dressings, the FDAers write.

The article reviews original PMAs, panel-track PMA supplements, PMA supplements, PMA real-time supplements, special PMA supplements, and PMA 30-day notices. It also discusses the ways dermatologists can contribute to the evaluation of medical devices.