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MedTech Current publications and recall entries tagged Device Classification.
The TGA's review identifies potentially regulated functions in eight of 12 digital scribes. Intended purpose, clinical outputs and conditional CDSS exemptions determine the applicable regulatory position.
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 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.
MDCG 2020-16 rev.5 clarifies the classification rationale and practical examples for Rule 7 control materials under IVDR, establishing key distinctions between unassigned Class B controls and assay-specific materials.
Australia's TGA announced amendments clarifying the Clinical Decision Support System exemption effective 1 November 2026, defining boundaries between excluded software, exempt CDSS, and regulated SaMD.
Under new Clause 2.2 of Australia's medical device regulations, non-invasive devices containing only saline for flushing or maintaining device patency are reclassified as Class IIa, with a five-year transition for existing products.