Siemens Healthineers (Nicole Zuk)

See attached file.

October 19, 2026

FDA Center for Devices and Radiological Health (CDRH)
FDA-2026-N-7874
VIA ELECTRONIC SUBMISSION – Federal Register

RE: Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and
Request for Feedback

Siemens Healthineers appreciates the opportunity to submit comments and contribute to the public
discussion on the FDA’s regulation of generative AI-enabled medical devices. Siemens Healthineers has a
longstanding commitment to the development of innovative medical products in the United States,
including those enabled by AI.

We are a leading global medical technology company including more than 17,000 passionate US
employees at research and development centers, manufacturing sites, and sales and service operations in
the United States. At Siemens Healthineers USA, we pioneer breakthroughs in healthcare for everyone,
everywhere, sustainably.

Our portfolio includes diagnostic and therapeutic imaging, laboratory diagnostics, molecular medicine,
digital health, and enterprise services. Our solutions are integral to informed clinical decisions across the
comprehensive healthcare landscape.

Our AI-enabled clinical solutions address major challenges in healthcare. Siemens Healthineers’ AIenabled clinical applications drive data-driven clinical decisions for millions of Americans by providing
otherwise unavailable quantitative data. Additionally, developing solutions for managing workforce
challenges and increasing workloads is crucial for long-term success. Siemens Healthineers has a portfolio
of AI-powered solutions that help advance more informed clinical decisions and automate and standardize
workflows to meet the needs of individual patients.

The future impact of healthcare technology and AI-enabled solutions is promising and transformative.
Ensuring their continued appropriate oversight and regulation is crucial to address the potential risks and
to bring the most innovative devices to the U.S. market.

Thank you for this opportunity to submit our perspective on this important topic.

Sincerely,

Nicole Zuk
Director, Health Policy and Government Affairs
Siemens Healthineers
The FDA’s Current Regulatory Framework is a Solid Foundation for Gen AI-enabled Devices.

The FDA’s current regulatory framework has effectively enabled the authorization of more than 1,500 AIenabled medical devices in the United States. Over the last decade, the FDA has evolved its thinking and
application of the existing framework to meet the rapid advancement of AI-enabled devices. This has
allowed for innovative medical devices to be developed in the U.S. and made available to U.S. patients.

The relatively recently created Predetermined Change Control Plan (PCCP) mechanism is an example of an
innovative regulatory approach that has allowed the FDA to ensure the safety and effectiveness of AIenabled devices through their lifecycle, including iterative modifications to support a device’s adaptation
and performance.

We are encouraged by the opportunity to build on this concept to reap the benefits of AI-enabled devices
while addressing their unique considerations.

We Welcome the Progress of AI-enabled Technologies to Help Address Workforce Challenges, including
to Meet the Needs of Rural Healthcare in the United States

AI-enabled devices have the potential to alleviate significant workforce challenges and expand clinical
capabilities, including for rural healthcare in the United States. AI-enabled technologies can help clinicians
in the provision of care as well as support patients directly in their healthcare journeys. These technologies
can improve health outcomes and address workforce issues by augmenting the work of clinicians,
automating procedures and coordinating patient care, thus increasing access to care, reducing variability
across workflow steps, decreasing time from diagnoses to treatment, improving operational efficiency,
and supporting patient engagement.

An appropriate regulatory framework that considers and balances the unique opportunities, with
oversight proportional to the risk of specific products, will allow these innovative devices to fulfill their
potential in improving the health of Americans.

Siemens Healthineers is Invested in the Development of Innovative Medical Technologies in the United
States.

We appreciate FDA’s global leadership and willingness to have an open discussion on innovative
regulatory approaches for Gen AI-enabled devices. FDA’s proactive stance on this important topic is
encouraging. Ensuring that innovative devices are available to U.S. patients while maintaining proper
oversight that is tailored to the intended use and risk of the device is critical.

Striking this balance is a challenge. We are a ready partner to continue to collaborate with the Agency
and broadly with healthcare providers, patients, and others in the AI-enabled healthcare ecosystem to
support responsible innovation in this space. We appreciate the FDA’s leadership and transparency in the
development of future regulatory approaches.