consultation

Stakeholders, including manufacturers and clinicians, must review and potentially revise their post-market vigilance and safety monitoring protocols in response to the FDA's proposed regulatory approaches for generative AI devices.

Stakeholders must prepare to submit comments regarding the proposed recommendations for PDUFA reauthorization by the deadline of October 16, 2026.

Manufacturers and stakeholders in South Korea must review and update their safety reporting systems and Standard Operating Procedures (SOPs) to comply with the revised regulations.

Regulatory teams must prepare for and implement processes for increased public disclosures and reporting obligations regarding medical device safety data in Australia.

MAHs and sponsors must review and potentially update internal SOPs and reporting forms that currently reference 'gender' to ensure compliance with the updated terminology and definitions.

Map this update to local PV compliance processes and update SOP/work instructions, ownership, and due dates for implementation evidence.

Regulatory Affairs teams must review the proposed data requirements and prepare for more rigorous documentation in registration applications and post-market monitoring.

Holders of Certificates of Registration and Clinical Research Organisations must update their safety databases and reporting workflows to comply with the new electronic reporting requirements for AEs and SAEs.

MAHs must prepare for updated risk management plans and post-marketing surveillance processes, reflecting the revised data requirements and definitions for biosimilars as per the NPL.

Implement increased documentation and reporting processes for traditional herbal medicinal products. Ensure staff receive training on the complexities involved in signal management for these products.

Sponsors must implement early communication strategies with the CDE regarding RWE study plans as a prerequisite for pediatric indication extension submissions.

Suppliers must implement new protocols for safety reporting and record-keeping as per the proposed framework.

Stakeholders must prepare for changes in how early-phase safety data is reported and engage in the continuous safety dialogue encouraged by the FDA. Ensure timely submission of comments by July 22, 2026.

Regulatory stakeholders should submit comments regarding the QMIN by the deadline of November 3, 2026, to influence the development and implementation of this initiative.

MAHs must align their workflows to accommodate the updated requirements for signal management and ICSR submissions as per the discussions in the ISG meeting.