While the FDA is proposing to reclassify two Class III computer-aided melanoma detection devices to Class II devices, most members of its panel on general and plastic surgery devices have suggested that such a move would be premature at the Medical Devices Advisory Committee meeting on Friday.
According to the FDA, reclassification of the MelaFind and Nevisense devices should be considered because the health risks associated with these skin lesion analyzers (SLAs) can be mitigated by a number of “special controls” that “provide reasonable assurance of its safety and efficiency.”
However, the general consensus among most panel members is that there is currently not enough information available to establish these special controls.
“My concern is that these devices need to show improvement over what a dermatologist can do,” said Karla Ballman, PhD, of Weill Cornell Medicine in New York. “At the moment, I don’t think we’re comfortable defining what sensitivity should be and what specificity should be. And even more so, what should be the relationship between the two. agreed on performance standards to be a Class II, and we don’t have that at this point, so I don’t think we’re ready to define what the special controls should be.
While these ALSs are a great need, said Maral Skelsey, MD, of the Washington Dermatologic Surgery Center in Chevy Chase, Maryland, “we’re just not ready for prime time, even with these special checks.”
Class III is the most stringent regulatory category for devices, and according to the FDA, Class III devices are generally high-risk devices for which there is insufficient information to provide reasonable assurance of safety and effectiveness only through general or special controls. In the case of a Class II device, general controls would not be sufficient to ensure safety and effectiveness. However, these devices contain enough information to establish special controls – such as performance standards or special labeling requirements – that would provide that assurance.
Thus, in the case of these computer-assisted melanoma detection devices, mitigating measures can be taken to control the associated risks, which 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 Devices and Infection Control. “That is, when the device is used correctly, the probable health benefits outweigh the probable risks, there is no unreasonable risk of illness or injury, and the device will provide clinically meaningful results in a significant portion of the target population.”
Murad Alam, MD, of Northwestern University in Chicago, noted that given the limited data available with only the two devices that have been approved by the FDA, “I struggle with the urgency of doing this. seems a bit premature given the lack of clarity in this space.”
According to Neil Ogden, BME, chief of the FDA’s general surgical devices branch, the reclassification of devices is not an unusual event. “We did that with hip and knee implants. We downgraded them from III to II,” he explained. “When we have enough information and believe we can regulate these devices in a lower class, we move to do so.”
This makes it easier for the FDA to get “high-quality devices that are safe and effective for the American population in the least burdensome way,” he added.
However, in addressing the issue of risks associated with service level agreements, the panel highlighted the issue of false negatives and positives as an area of great concern.
For example, Skelsey pointed out that due to numerous false positives, “my real-world experience is that I’ve given up on a device because it wasn’t functional in a dermatology office.”
“There needs to be more testing, especially around the issue of false negatives and false positives,” said Neil Farber, MD, of the University of California, San Diego. “It’s such a risk and such a complex issue because you have a [artificial intelligence] device on the one hand and interaction with dermatologists on the other. I think we need real-world and real-use types of studies. And those should be forward-looking.”
While the majority of panel members indicated they were not in favor of reclassifying the devices, others disagreed.
Katalin Roth, MD, JD, of George Washington University in Washington, DC, said she thought it would be appropriate to downgrade the devices as long as the special controls were clear the devices were only used by dermatologists only with training and with informed consent. of sick.
SLAs in development
While Friday’s meeting focused on the two devices that have already received FDA approval, the panel on Thursday discussed how the FDA should proceed to assess the benefits and risks of computer-assisted ALSs. which are currently under development.
Much of the discussion focused on performance thresholds for devices intended for adjunctive use by dermatologists and non-dermatologists (i.e. management). Such a device could be used by laypersons, as well as medical professionals.
In general, the panel resisted the idea of using predefined thresholds to assess the performance of these devices. “Nobody seems comfortable with the idea of providing a generalized, predefined threshold of sensitivity/specificity,” said panel chair Hobart W. Harris, MD, MPH, University of California, San Francisco, summarizing the panel’s point of view.
“I don’t think absolute sensitivity and specificity measurements … will be enough for us to consider these devices,” said Veronica Rotemberg, MD, PhD, of Memorial Sloan Kettering Cancer Center in New York. “The best kind of test for these devices is going to be a prospective study in the setting of intended use rather than a threshold on retrospective data, and in that setting of intended use, improvement as defined by a value judgment on the standard of care in this setting.”
“I agree that in the complementary framework, you want to see if it increases accuracy – however you define it – over where it is now,” Alam said. “I’m not that concerned about the FDA regulating add-on devices – it looks like the FDA has that pretty well under control. The potential issues are those devices that are going to be for the general public and are going to be marketed very aggressively. .”
Once these devices are FDA-sanctioned “no one will really think about the nuance of how they work or what they’re for, they’ll just say they’re FDA-approved,” he added. “So it’s a high bar for us that what comes out is reasonably good. I’d like it to be a sensitivity of at least what a dermatologist would, and ideally a bit more.”