Topic archive
MedTech Current publications and recall entries tagged Software & SaMD.
FDA's October 20 update highlights hypothetical pathways for hospital-specific sepsis models and automated ECG model retraining. The examples connect planned changes with validation, controlled deployment and continued oversight, without authorizing unrestricted learning.
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.
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.
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.
Losing CGM connectivity changes how the insulin pump operates: users must manage delivery in manual mode without the app’s glucose values or automated control. For connected-device teams, the failure links release controls and sensor-compatibility testing to the ability to restore a working production version quickly.
A reproduced NMPA consultation draft combines general GMP and software provisions in a graded inspection checklist. Its clauses distinguish critical and major controls and specify lifecycle traceability and cloud responsibilities; the current copy remains unauthenticated against the official original.
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 issue affects radiotherapy dose-checking software and can create a mismatch between calculated and delivered treatment setup if the bolus requirement is missed. Although the quantity is small, the consequence is clinically meaningful because the limitation concerns delivered dose depth.
The Russian Ministry of Health has enacted Order No. 421n, replacing Order No. 885n to establish updated rules for technical testing, toxicological evaluation, and clinical investigations for state registration.
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.
PMDA has updated the currently available timing for face-to-face consultations conducted by its Programmed Medical Device Review Office, with scheduling now shown as November 2026 and later. The update is a consultation-capacity notice rather than a change to the statutory or standard review timeline for SaMD approvals.
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.