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Review and update data submission practices to align with the new technical specifications; ensure compliance with FDA-supported data standards.

Identify and remove affected devices from use until corrected; if use is necessary, follow additional precautions provided in the GE HealthCare customer letter.

Do not use VCV mode until corrected. Use PCV or PCV-VG mode. Perform Ventilation Screening Test. Return acknowledgement form to GE HealthCare.

Review the specific labeling changes required by the FDA order and update internal safety documents and signal evaluation for ADZYNMA accordingly.

Review product inventory for Tawon Liar; report any adverse events to FDA MedWatch; consider adding product to signal monitoring list; ensure labeling compliance checks for similar products.

Immediately quarantine and return unused MonaTherm probes from affected lots; review patient records for potential exposure and adverse events.

1) Verify your internal signal assessment narrative for GLP-1 RAs reflects FDA’s statement that the preliminary evaluation does not suggest a causal link; 2) Check whether any company-facing statements, FAQs, or labeling change proposals referencing suicidality need to be updated for consistency with FDA’s current public position; 3) Log the FDA update in regulatory intelligence tracking and maintain monitoring for further FDA conclusions or requests (including the linked 13 Jan 2026 communication).

Ask the safety/device vigilance and PV CSV leads to: (1) confirm whether any marketed/fielded SaMD/AIaMD uses adaptive ML or planned updates that would fit a PCCP-like approach; (2) review current change-control SOPs and technical documentation to ensure change governance and transparency artifacts are captured and retrievable; (3) verify post-market/vigilance processes explicitly account for algorithm updates (e.g., monitoring after updates, escalation criteria).

1) Inventory AI use cases that could feed regulated decisions (including PV/safety-related analyses or summaries used in regulatory interactions) and map owners/vendors. 2) For each AI use case, document context of use, intended outputs, and controls (e.g., review/approval, traceability, change management) aligned to a draft-guidance tracking plan. 3) Track the Federal Register notice and plan whether to submit comments within the window described by FDA (90 days after Federal Register publication).

Fda update requires triage for Signal Validation, Local Affiliate Compliance, Device Vigilance; confirm local obligations and document follow-up actions.

Fda update requires triage for Local Affiliate Compliance, ICSR Submission, Device Vigilance; confirm local obligations and document follow-up actions.