Topic archive
MedTech Current publications and recall entries tagged Digital & Connected Health Regulation.
FDA has finalized its approach to labeling for software distributed by drug sponsors, distinguishing FDA-required labeling from promotional labeling while retaining the separate medical-device framework.
The TGA has completed its review of the conditional exclusion for certain digital mental health tools, finding that the criteria may allow higher-risk products to remain outside its oversight. Public consultation on regulatory options is planned for 2026; the update does not establish a final replacement rule or commencement date.
MHRA plans an adaptive framework for AI medical devices, a Centre for AI and Digital Health, and stronger lifecycle data and traceability. The 14 October strategy sets future priorities; planned UDI measures remain subject to the parliamentary process.
PMDA has made its September draft review points for generative AI medical devices available in English. The draft discusses clinical scope, performance testing, supplier dependencies and life-cycle risk management; the translation introduces no newly effective requirements.
An FCC public draft proposes modernizing Part 15 UWB rules and seeks comment on a possible AI-based sensing class. Health-monitoring developers should assess device classification, emissions and measurement methods under the current framework.
MFDS issued nonbinding guidance on September 30, 2026, for digital medical software that patients use under healthcare professional diagnosis, direction or supervision. It clarifies application information, separate professional and patient instructions, supporting evidence for standalone software and a disclosure checklist.
The US FCC has opened a public comment period on specific radiofrequency exposure issues remanded in Environmental Health Trust v. FCC, while existing RF exposure limits and applicable compliance requirements remain in effect.
The US FCC has issued a final rule barring equipment authorization for devices containing logic-bearing hardware components from Covered List entities, applying prospectively from October 13, 2026.
FCC has proposed a framework that would let certain unlicensed devices communicate with satellites on a non-interference basis and is seeking comment through November 9, 2026. Medical-device teams that rely on wireless modules, connected accessories, or supplier RF roadmaps should check whether the proceeding could affect future band planning, coexistence assumptions, or certification strategy.
FCC has issued a correction to the July 31, 2026 final rule on Upper C-Band flexible use, correcting minor editorial errors and the stated number of years in the first and second performance benchmarks. For teams using the rule in wireless planning, certification support, or regulatory summaries, the practical task is to update internal references to the corrected text.
The 25 August 2026 update to the UK AI Research Resource page only adds AMD to the partner list; it does not introduce a new AI or digital-health regulatory requirement. For healthcare AI and R&D teams, the more important opportunity is the existing access to Isambard-AI and Dawn through routes such as Rapid Access and Gateway.
FDA has issued a discussion paper seeking feedback on how generative AI-enabled medical devices should be assessed across risk classification, premarket evaluation, and postmarket monitoring. The paper outlines possible approaches including a two-axis risk framework and competency-based premarket assessment, but it does not establish new regulatory requirements.