The U.S. Food and Drug Administration (FDA) is holding a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee to discuss the topic of skin lesion analyzer technology and its application to detecting skin cancers in various patient care settings. The committee will also discuss the potential reclassification of approved computer-aided melanoma detection class III devices.
The meeting will be held virtually on July 28, 2022, from 9 a.m. to 5:45 p.m. Eastern Time and July 29, 2022, from 9 a.m. to 4 p.m. Eastern Time. Registration is not required to attend.
The FDA noted that it is convening this committee to promote an open public discussion of, and seek expert opinion on, currently available scientific and clinical data pertaining to the diagnosing standard also known as ground truth, performance criteria and patient population in future studies assisting medical providers in properly identifying skin lesions by a computer algorithm-aided device.
The committee will be asked to discuss and provide recommendations regarding:
- The diagnosing standard, or ground truth, based on factual data that should be used as a comparison for the performance of diagnostic devices including, but not limited to, histology, consensus opinion of a panel of dermatologists, opinion of a single dermatologist, or other means.
- Acceptable thresholds for sensitivity and specificity based on the target diagnosis (melanoma, basal cell carcinoma (BCC), squamous cell carcinoma (SCC)), or on the intended user (dermatologist, primary care physician, lay user) if assessed for standalone performance.
- Patient characteristics, including lower or higher incidence populations, that should be tested before marketing.
- Balance of increased access with risk mitigation measures that are appropriate when the devices are used by lay people, by populations with very high or very low incidence of melanoma, by populations with low incidence, but high mortality associated with melanoma, or by the target diagnosis/lesion type (melanoma, BCC, SCC)
On July 29, the committee will discuss the possible reclassification of two approved computer-aided melanoma detection class III devices: MelaFind, a device that uses multispectral imaging, and Nevisense, a device that measures impedance. Both devices are intended for use on cutaneous lesions suspicious for melanoma when a dermatologist chooses to obtain additional information when considering biopsy. The committee will discuss if there is sufficient information to reclassify computer-aided devices for adjunctive diagnostic information of lesions suspicious for melanoma from class III to class II, and what special controls may be appropriate to provide reasonable assurance of safety and effectiveness for these devices if they are reclassified as class II devices.
Oral presentations from the public will be scheduled on July 28, between approximately 1 p.m. and 2 p.m. Eastern Time, and on July 29 between approximately 1 p.m. and 2 p.m. Eastern Time. Individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before June 28, 2022. The contact person will notify interested persons regarding their request to speak by June 29, 2022.
CONTACT: Candace Nalls, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993-0002, 301.636.0510, Candace.Nalls@fda.hhs.gov.
Comments received on or before July 11, 2022, will be provided to the committee. Comments received after that date will be taken into consideration by FDA. Comments can be submitted electronically through the Federal eRulemaking Portal.