FDA UPDATE January 22, 2020

FDA Reclassification Updates

Earlier this week, the FDA issued a final order which reclassified several families of medical devices. These devices include certain radiological medical image analyzer such as Computer-Assisted Detection (CADe) devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection devices. These devices have been reclassified from Class III devices to Class II devices, subject to a 510(k) premarket notification. This order also provides special controls in addition to general controls, which provide a reasonable assurance of safety and effectiveness for these CADe devices. This reclassification has been implemented in hopes that the FDA can streamline the review period for these types of devices to allow these devices to be marketed to patients in a more timely matter. To reflect the reclassifications in this order, the FDA has updated the guidance, “Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions”.

mdi has been working with CAD devices for over 10 years assisting clients with the their regulatory strategy and obtaining FDA approval (clearance) to market. If your company requires any assistance with obtaining 510(k) clearance for a Computer-Assisted Detection devices, feel free to contact us at info@mdiconsultants.com RE: CADe Device.