As the FDA is proposing to reclassify two class III computer-aided melanoma detection devices as class II devices, most members of its General and COSMETIC SURGERY Devices Panel suggested that this type of move will be premature through the Medical Devices Advisory Committee meeting on Friday.
Based on the FDA, reclassification of the MelaFind and Nevisense devices is highly recommended as the risks to health connected with these skin lesion analyzers (SLAs) could be mitigated by way of a amount of “special controls” that “give a reasonable assurance of its safety and effectiveness.”
However, the overall consensus among most panel members is that there currently isn’t enough available information to determine those special controls.
“My concern is these devices have to show a noticable difference over just what a dermatologist can perform,” said Karla Ballman, PhD, of Weill Cornell Medicine in NEW YORK. “At this time I don’t believe we have been comfortable setting what the sensitivity ought to be, and what the specificity ought to be. And much more so, what the partnership between your two ought to be. You must have arranged performance standards to become a class II, and we don’t possess that at this time. So, I don’t believe we’re prepared to define what the special controls ought to be.”
While these SLAs represent a location of great need, said Maral Skelsey, MD, of the Dermatologic Surgery Center of Washington in Chevy Chase, Maryland, “we’re not ready for prime time, despite having these special controls.”
Class III may be the most stringent regulatory category for devices, and based on the FDA, class III devices are usually high-risk devices that insufficient information exists to supply reasonable assurance of safety and effectiveness solely through general or special controls. Regarding a class II device, general controls wouldn’t normally be enough to supply assurance of safety and efficacy. However, there’s enough information with one of these devices to determine special controls — such as for example performance standards or special labeling requirements — that could provide this assurance.
Thus, regarding these computer-aided melanoma detection devices, mitigation measures could be taken up to control for associated risks, that could include false-negative or false-positive results, user error or improper device use, or device failure or malfunction, said Scott Kominsky, PhD, of the FDA’s Office of Surgical and Infection Control Devices. “In other words, once the device can be used properly, the probable benefits t0 health outweigh the probable risks, there isn’t an unreasonable threat of illness or injury, and these devices provides clinically significant results in a substantial portion of the prospective population.”
Murad Alam, MD, of Northwestern University in Chicago, noted that given the limited data available with only both devices which have been FDA approved, “I’m fighting the urgency to get this done. It seems if you ask me just a little premature given having less clarity in this space.”
In accordance with Neil Ogden, BME, chief of the FDA’s General Surgery Devices Branch, reclassifying devices isn’t a unique occurrence. “We did this with hip and knee implants. We down-classified them from III to II,” he explained. “Whenever we have sufficient information, and we think we are able to regulate the unit in a lesser class, we proceed to achieve this.”
That eases the procedure for the FDA to obtain “high-quality devices which are effective and safe to the U.S. population whatsoever burdensome manner,” he added.
However, when addressing the question of the risks connected with SLAs, the panel highlighted the problem of false negatives and positives being an section of great concern.
For instance, Skelsey remarked that because of numerous false positives, “my real-world experience is I abandoned a tool since it wasn’t functional in a dermatology office.”
“There must be more testing, especially round the problem of false negatives and false positives,” said Neil Farber, MD, of the University of California NORTH PARK. “It’s this type of risk and this type of complex issue as you have an [artificial intelligence] device on the main one hand and an interaction with dermatologists on another. I think we are in need of some real-world, real-use forms of studies. And the ones would need to be prospective.”
As the most panel members indicated these were not and only reclassifying the devices, others disagreed.
Katalin Roth, MD, JD, of George Washington University in Washington, D.C., said that she believed down-classifying the devices will be appropriate so long as special controls were clear, the devices were utilized by dermatologists only with training, sufficient reason for informed consent of patients.
SLAs in Development
While Friday’s meeting centered on both devices which have already received FDA approval, on Thursday the panel discussed the way the FDA is going about evaluating the huge benefits and risks of computer-aided SLAs which are currently in development.
A lot of the discussion centered round the performance thresholds of devices designed for adjunctive use by dermatologists and non-dermatologists (i.e., primary care physicians), along with performance thresholds for standalone devices (meaning the output will be relied upon at face value to steer management). This type of device could possibly be utilized by lay-persons, and also healthcare professionals.
Generally, the panel resisted the thought of using preset thresholds to judge the performance of the devices. “Nobody appears to be more comfortable with providing a preordained, across-the-board sensitivity/specificity threshold,” said Panel Chair Hobart W. Harris, MD, MPH, of the University of California SAN FRANCISCO BAY AREA, in summarizing the panel’s view.
“I don’t believe absolute sensitivity and specificity measures … will be sufficient for all of us to consider the unit,” said Veronica Rotemberg, MD, PhD, of Memorial Sloan Kettering Cancer Center in NEW YORK. “The very best kind of test for the unit will likely be a prospective study in the intended-use setting rather than threshold on retrospective data, and for the reason that intended-use setting, improvement as defined by way of a value judgment on the standard of care for the reason that setting.”
“I’d concur that in the adjunctive setting you wish to see if it’s increasing accuracy — nevertheless, you define that — over where it’s currently at,” said Alam. “I’m not worried about FDA regulation of devices which are for adjunctive use — it appears the FDA includes a very good handle on that. The potential problems are the unit that will maintain the lay public and so are likely to be marketed very aggressively.”
Once the unit are sanctioned by the FDA “nobody will think concerning the nuance of how they work or what they’re intended for, they’ll just say they’re FDA-approved,” he added. “So it is a higher bar for all of us that what gets on the market is fairly good. I’d like it to become a sensitivity of at the very least just what a dermatologist would do, and ideally, a bit more.”
Mike Bassett is really a staff writer concentrating on oncology and hematology. He could be located in Massachusetts.