Topic archive
MedTech Current publications and recall entries tagged 510(k).
The Class II rule covers home specimen collection followed by clinical laboratory testing, not at-home result generation. Existing classification controls address the collection device, specimen-specific evidence, shipping integrity and user information.
The 9 October 2026 rule codifies a classification applicable since November 2023. Its seven groups of special controls connect sensor quality, clinical performance, alarms, usability and labelling; the device type remains subject to 510(k).
FDA codified Class II special controls for room-temperature vascular autograft flushing and storage solutions. Six control categories govern the device type, while the original DuraGraft indication’s four-hour duration is product-specific. Developers should distinguish those two sources of requirements.
The US FDA has issued a final order denying an industry petition seeking partial 510(k) premarket notification exemptions for radiology CADe, CADx, and CADt software devices under 21 CFR Part 892.
The US FDA has issued a final order codifying cardiovascular machine learning-based notification software under 21 CFR 870.2380 as Class II (special controls), establishing a 510(k) pathway while excluding arrhythmia detection.
FDA has issued two final 510(k) guidances covering dental composite resin devices and dental curing lights, replacing guidance documents from 2005 and 2006. The final versions update FDA's recommendations for device description, performance testing, and labeling, including clarified shelf-life testing for composite resins and revised radiant-power testing expectations for curing lights.
FDA’s general draft guidance on Predetermined Change Control Plans remains in draft status, but section 515C of the FD&C Act is already in effect and manufacturers may submit PCCPs today. The draft explains what planned device modifications may be appropriate for a PCCP and the information FDA expects manufacturers to provide.