FDA approves melanoma diagnostic device
MelaFind, a computer-assisted melanoma-detecting device developed by MELA Sciences, has received FDA pre-market approval (PMA) for use on atypical cutaneous pigmented lesions.
The indication states that MelaFind only be used on lesions between 2mm and 22mm in diameter, that are accessible using the device's imaging tool and have sufficient pigmentation.
Other indication criteria specify that the lesions be: without scar or fibrosis; non-ulcerated and non-bleeding; not on acral, palmar, plantar, mucosal, or subungual areas; and located >1 cm from eyes.
The device is not intended to confirm clinical melanoma diagnoses, the manufacturer emphasized, but is indicated for dermatologists who wish to obtain more information before making a decision to biopsy a lesion.
Additionally, MelaFind is not indicated for use on pigmented non-melanoma skin cancer lesions and dermatologists must successfully complete a training program before using the device.
The approval comes after much back and forth between the manufacturer, MELA Sciences, and the FDA. The first marketing approval application was submitted in June 2009, but at that time the FDA told manufacturers that the device was unapprovable.
After MELA Sciences revised and resubmitting the application, the FDA's General and Plastic Surgery Devices Committee voted 8-7 (one member abstained) in favor of approving the device in November 2010.
Even though data from two clinical trials involving 1,400 patients with lesions indicated that MelaFind had a higher specificity in recommending lesions for biopsy than study clinicians (9.5% vs. 3.7%; P<0.05), panel members expressed concern about the device's efficacy in routine clinical practice and emphasized that it was not a substitute for clinical judgement.
Additional discussions with the FDA lead the manufacturer to revise its application again in March 2011. But when the FDA still had not reached a decision regarding the device's approval in June 2011, MELA Sciences filed a citizen's petition criticizing the agency for slow decision making and changing demands.
The FDA's final decision to grant MelaFind PMA came after careful deliberation concerning the wording of the product's labeling. MELA Sciences has since withdrawn its citizen's petition against the agency.