Device manufacturers may see the EU MDR extension as an opportunity to take their collective feet off the gas. But slowing down or pausing a device’s testing program could jeopardize a successful transition and exacerbate the problem the deadline extension was designed to fix.
The committee will be discussing skin lesion analyzer technology and its application in detecting skin cancers in various patient care settings as well as the potential reclassification of approved computer-aided melanoma detection class III devices.
FDA premises device classification based on risk: Low-risk devices are Class I and high-risk devices are Class III. Then, just maybe, Class II is medium-risk? Well, sort of.