American Association of Nurse Anesthesiology (Tracy P. Young)

See attached.

October 14, 2026

The Digital Health Center of Excellence (DHCoE)
Center for Devices and Radiological Health (CDRH)
Food and Drug Administration
Submitted via: https://www.regulations.gov/docket/FDA-2026-N-7874

RE: Considerations for the Regulation of Generative AI-Enabled Medical Devices:
Discussion Paper and Request for Feedback [FDA-2026-N-7874-000]

On behalf of more than 71,000 members, the American Association of Nurse
Anesthesiology (AANA) submits these comments to the FDA’s request for feedback on
CDRH’s discussion paper regarding regulation of generative-AI (GenAI) enabled
medical devices.

AANA is the professional association representing Certified Registered Nurse
Anesthetists (CRNAs) and Student Registered Nurse Anesthetists (SRNAs) nationwide.
CRNAs are Advanced Practice Registered Nurses (APRNs) who are doctorally prepared
autonomous anesthesia providers through their training and preparation. CRNAs
provide the full spectrum of expert anesthesia and pain management care across
diverse clinical settings and are trained and licensed to care for all patients, including
those with complex medical conditions.

AI tools, assistance, and enabled devices have the potential to increase efficiency,
advance research, and improve patient safety in anesthesia care delivery. However,
any policymaking in this field must incorporate the expertise of CRNAs and support
their clinical decision-making, not supersede it. CRNAs’ direct experience and input is
critical as those who use these tools in direct patient care, especially in rural and
underserved communities, where CRNAs are the predominant provider of anesthesia
care.1 In rural counties, for instance, CRNAs represent over 80 percent of all
anesthesia providers. 2 Facilities in these areas struggle with anesthesia provider
shortages and thin margins, causing access gaps that require efficient solutions that
maintain the highest levels of patient safety. Reliance on the leadership of CRNAs is
necessary for AI healthcare policy that expands access to high-quality safe patient
care where it is needed most.
Liao, C.J., Quraishi, J.A., & Jordan, L.M. (2015). Geographical Imbalance of Anesthesia Providers and its Impact On the
Uninsured and Vulnerable Populations. Nursing economic$, 33 5, 263-70.
Martsolf GR, Baird M, Cohen CC, Koirala N. Relationship Between State Policy and Anesthesia Provider Supply in Rural
Communities. Med Care. 2019;57(5):341-347. doi:10.1097/MLR.0000000000001106.
Therefore, AANA asserts several guiding policy positions to lead AI regulatory frameworks
to utilize CRNA expertise and advance CRNA practice. These include:

1. Any AI tools, decision-support systems, or AI technology cannot replace CRNA
skills, knowledge, and expertise as critical members of the healthcare workforce.
CRNAs retain independent professional judgment when using AI and decisionsupport tools.3
2. Any development of AI-related regulations or guidance must include direct CRNA
involvement to ensure that the perspective and clinical practice of nursing and
nurse anesthesiology are accurately represented.
3. CRNAs are prepared, educated and licensed as independent practitioners;
therefore, AI technology and decision-support tools must not be used within any
practice models to facilitate or expand supervision, beyond what is required by
federal or state law.

Additionally, AANA has established eight foundational principles to guide the development
and implementation of AI in anesthesia care in response to the National Science
Foundation’s RFI to develop an AI Action Plan.4 These principles are recommendations
from ensuring AI is a tool and not a replacement, to the necessity of interdisciplinary
collaboration to ensure technology aligns with clinical realities.

AANA urges the FDA to incorporate these policy positions and foundational principles as
part of its considerations for the regulation of GenAI-enabled devices. Specifically, AANA is
responding to the following questions in the discussion paper:

Question 4: Who qualifies as a specialist when evaluating risk?
AANA recommends that FDA use the term "qualified clinicians with relevant clinical
expertise" to include and recognize the knowledge, skills, and expertise of all qualified
clinicians involved in patient care rather than limiting this assessment to a distinction
between generalist and specialist physicians.

The appropriate level of clinical expertise should be determined by the intended use of the
GenAI-enabled medical device, the clinical functions it performs or supports, the patient
American Association of Nurse Anesthesiology. Code of Ethics for the Certified Registered Nurse Anesthetist. April
2026. Available at:
https://issuu.com/aanapublishing/docs/code_of_ethics_for_the_certified_registered_nurse_?fr=sZGY1YTU2NDAxMjU.
American Association of Nurse Anesthesiology. Request for Information on the Development of an AI Action Plan.
February 27, 2025. Available at: https://www.aana.com/wp-content/uploads/2025/03/AANA-comments-on-RFIDevelopment-of-an-AI-Action-Plan.pdf.
population, and the environment in which it will be used. Healthcare professionals other
than physicians may possess specialized education, training, certification, and clinical
expertise relevant to evaluating the risks associated with a particular device or clinical
function.

Specifically, CRNAs provide the full spectrum of anesthesia, pain management, and
related care across diverse healthcare settings, including hospitals, non-operating room
anesthetizing locations, ambulatory surgical centers, office-based practices, and
community health facilities. CRNAs deliver anesthesia services for surgical, diagnostic,
therapeutic, and interventional procedures. Their practice encompasses, but is not limited
to, the entire perioperative continuum, including preoperative assessment and
optimization, development of individualized anesthetic plans, administration and
management of anesthesia, physiologic monitoring and stabilization, acute and chronic
pain management, and post-anesthesia recovery care.5 CRNAs exercise independent
professional judgment and adhere to strict practice standards, prioritizing patient safety.6
When a GenAI-enabled medical device is intended to perform or support functions related
to anesthesia care, CRNAs should be included among the qualified clinicians involved in
evaluating the device's potential risks.

AANA therefore recommends that FDA use "qualified clinicians with relevant clinical
expertise" and determine the appropriate expertise based on the device's intended use and
clinical function rather than professional title alone.

Question 14: Who should serve as the clinical comparator when evaluating AI
performance?
AANA recommends that the appropriate clinical comparator reflect the qualified
healthcare professional or interdisciplinary clinical team with the education, training,
experience, and clinical expertise necessary to perform the activity represented by the
device's intended use.

Clinical performance standards should not be limited to comparisons with generalist or
specialist physicians when other qualified healthcare professionals, including CRNAs,
routinely perform the clinical function being evaluated. Selecting comparators based on
relevant knowledge, skills, and clinical expertise would provide a more accurate
American Association of Nurse Anesthesiology. Scope of Nurse Anesthesia Practice. April 2026. Available at:
https://issuu.com/aanapublishing/docs/scope_of_nurse_anesthesia_practice_2.23?fr=sNDg2MDU2NDAxMjU.
American Association of Nurse Anesthesiology. Standards for Nurse Anesthesia Practice. August 2026. Available at:
https://issuu.com/aanapublishing/docs/standards_for_nurse_anesthesia_practice_2.23?fr=sOGNhNjU2NDAxMjU.
assessment of how a GenAI-enabled medical device performs within its intended clinical
environment.

For GenAI-enabled medical devices intended to perform or support functions related to
perioperative care, anesthesia care, and pain management, CRNAs should be represented
in the development of performance standards and participate as clinical comparators,
expert adjudicators, or members of clinical evaluation panels.

AANA encourages FDA to adopt an inclusive, function-based approach in which the
appropriate comparator is determined by the device's intended use, clinical function,
patient population, and practice environment, rather than by professional title alone. When
a device supports care delivered by an interdisciplinary team, evaluation should also
consider whether comparison with the relevant clinical team better reflects real-world
practice.

Question 21: What role should professional societies and clinicians play in ongoing AI
safety monitoring?
Professional societies, such as the AANA, and clinicians, such as CRNAs, can provide
valuable specialty-specific expertise in post-market monitoring of GenAI-enabled medical
devices. CRNAs who provide direct patient care are positioned to observe how these
technologies perform within real-world clinical environments and may identify safety or
performance concerns that are not apparent during premarket evaluation. AANA should be
involved in the development of any specialty-specific AI guidelines, resources, and
education.

Through the information provided by CRNAs, AANA can support post-market monitoring by
helping identify and communicate:
• emerging patient safety concerns and potential safety signals
• unintended clinical consequences
• workflow and implementation challenges
• specialty-specific performance issues
• clinician education and competency needs
• patterns or concerns reported by clinicians
• use of GenAI-enabled medical devices in ways that extend beyond or differ from
their intended use

Professional societies serve as an important two-way communication channel among
clinicians, healthcare organizations, manufacturers, regulators, and other stakeholders by
helping aggregate specialty-specific observations and identify trends that warrant further
evaluation as well as communicate important information to the society’s membership in a
direct, timely fashion.

AANA supports the development of mechanisms that allow clinicians and professional
societies to communicate emerging patient safety signals and real-world performance
concerns to the FDA and manufacturers. Such mechanisms should be clearly defined,
accessible, and designed to facilitate meaningful feedback from clinicians using these
technologies in practice.

Participation by clinicians, healthcare institutions, and professional societies in postmarket safety monitoring should not transfer or dilute manufacturer responsibility for the
safety, effectiveness, quality, and ongoing performance of their devices. Manufacturers
should retain primary responsibility for appropriate post-market surveillance, evaluation of
safety signals, and corrective action when warranted.

We appreciate CDRH’s careful approach to collecting the necessary information on
regulating GenAI-enabled devices. CRNA expertise will be critical in the policymaking
process for this technology. AANA welcomes additional stakeholder feedback
opportunities and looks forward to discussing with your agency the forthcoming AANA
Position Statement, “Artificial Intelligence in Nurse Anesthesia Practice.” Should you have
any questions please contact Ewa Greenier, Senior Director of Practice and Patient Safety
at egreenier@aana.com and Romy Gelb-Zimmer, Director of Regulatory Affairs at
rgelbzimmer@aana.com.

Sincerely,

Tracy P. Young, MSNA, MBA, CRNA
AANA President