The ALS Association (Richard D. Brennan Jr.)

The ALS Association appreciates the opportunity to comment on the Food and Drug Administration’s discussion paper, Considerations for the Regulation of Generative AI-Enabled Medical Devices. We welcome FDA’s early engagement with patients and other stakeholders as the Agency considers how best to regulate these rapidly evolving technologies.

Amyotrophic lateral sclerosis (ALS) is a progressive and fatal neurodegenerative disease that can result in the irreversible loss of speech, mobility, swallowing, respiratory function, and independence. For people living with ALS, medical technologies can become essential to communicating, breathing with support, moving safely, participating in medical decisions, and maintaining independence and connection with others. The Association has previously emphasized to FDA that medical technologies are often central to communication, mobility, respiratory function, independence, and quality of life for people living with ALS.

Generative artificial intelligence (GenAI) has the potential to make medical and assistive technologies more responsive, accessible, and useful. It can also introduce new risks, particularly as AI-generated or AI-interpreted information becomes increasingly personalized or begins to influence clinical decisions and connected technologies.

The ALS Association encourages FDA to establish a GenAI framework that is patient-centered, scientifically rigorous, risk-proportionate, and predictable. The framework should support responsible innovation while preserving patient safety, agency, and trust.

SUBMITTED ELECTRONICALLY VIA FDA.GOV

October 16, 2026

Dockets Management Staff
U.S. Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

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

Dear Acting Commissioner Diamantas:

The ALS Association appreciates the opportunity to comment on the Food and Drug Administration’s
discussion paper, Considerations for the Regulation of Generative AI-Enabled Medical Devices. We
welcome FDA’s early engagement with patients and other stakeholders as the Agency considers how
best to regulate these rapidly evolving technologies.

Amyotrophic lateral sclerosis (ALS) is a progressive and fatal neurodegenerative disease that can result in
the irreversible loss of speech, mobility, swallowing, respiratory function, and independence. For people
living with ALS, medical technologies can become essential to communicating, breathing with support,
moving safely, participating in medical decisions, and maintaining independence and connection with
others. The Association has previously emphasized to FDA that medical technologies are often central to
communication, mobility, respiratory function, independence, and quality of life for people living with
ALS.

Generative artificial intelligence (GenAI) has the potential to make medical and assistive technologies
more responsive, accessible, and useful. It can also introduce new risks, particularly as AI-generated or
AI-interpreted information becomes increasingly personalized or begins to influence clinical decisions
and connected technologies.

The ALS Association encourages FDA to establish a GenAI framework that is patient-centered,
scientifically rigorous, risk-proportionate, and predictable. The framework should support responsible
innovation while preserving patient safety, agency, and trust.

Risk Should Reflect Function and Consequence

The ALS Association supports a risk-based approach that considers what a GenAI-enabled medical device
is intended to do and the consequences of an incorrect output.
Patient-facing use or disability should not, by itself, determine that a device presents greater risk. People
living with serious and progressive diseases often become highly knowledgeable about their health,
symptoms, treatment preferences, and the technologies they use. Many people living with ALS regularly
rely on sophisticated communication, respiratory, mobility, and monitoring technologies.

FDA should instead consider factors such as the intended function, degree of autonomy, consequences
of an error, whether an error is detectable and reversible, and whether the patient or clinician has a
meaningful opportunity to intervene.

This approach can protect patients while preserving the potential for GenAI-enabled technologies to
improve access to information, support patient engagement, and strengthen participation in care.

The ALS Association supports risk-based oversight of GenAI-enabled medical devices based on
function and potential harm, not simply who uses the technology.

Patients Should Help Define Meaningful Performance

Technical accuracy alone may not fully describe whether a patient-facing GenAI-enabled medical device
performs successfully.

Depending on the intended use, meaningful performance may also depend on whether patients can
access and understand the technology, communicate effectively through it, recognize important
limitations, and correct an output that does not reflect their intent.

This is particularly important for people living with ALS and other conditions affecting speech and
movement. Evaluation should reflect the people who will use the technology and the circumstances in
which it will be used. For ALS, this may include people experiencing changes in speech or motor
function, people using augmentative and alternative communication (AAC) systems or other alternative
input methods, and situations in which caregivers assist with the use of technology.

People living with ALS and caregivers can help identify outcomes and potential failures that matter most,
including whether a technology reliably communicates an individual’s wants, needs, choices, and urgent
concerns; remains accessible as abilities change; communicates uncertainty understandably; preserves
the individual’s intended communication; and supports meaningful participation in health care decisions.

The ALS Association has previously emphasized that meaningful outcomes for people living with ALS may
include reliable communication, participation in medical decisions, independence, respiratory support,
usability, caregiver impact, social participation, and quality of life.

The ALS Association encourages FDA to promote early, fit-for-purpose engagement with patients,
caregivers, and patient organizations when patient interaction is important to the safety or effectiveness
of a GenAI-enabled medical device.

Patients should not simply participate in testing after development decisions have been made. Patient
experience should help define evaluation priorities and meaningful performance.
Evidence Should Be Rigorous, Fit for Purpose, and Representative of Intended Users

The ALS Association supports rigorous evidence requirements appropriate to a device’s intended use,
patient population, level of autonomy, and the potential consequences of an incorrect output.

Benchmarking can provide useful information about a GenAI-enabled device’s capabilities and potential
failure modes. However, when a device’s safety or effectiveness depends on patient interaction,
communication, comprehension, accessibility, or usability, evaluation should also include evidence
representative of intended users and realistic conditions of use.

For example, an AI-enabled assistive communication technology intended for people with impaired
speech or motor function should not be considered fully evaluated based solely on performance using
standardized or general-population inputs.

Synthetic data may provide useful opportunities to examine uncommon scenarios, potential failure
modes, and limited datasets, including in rare diseases. However, synthetic data should not routinely
substitute for direct patient evidence when the regulatory question depends on how patients
understand, access, communicate through, or act upon the technology.

FDA should also consider the real-world alternative available to patients when evaluating potential
benefit. Depending on the intended use, the relevant alternative may include existing technology,
unaided clinical judgment, delayed specialist review, or no timely intervention. This should not lower the
evidence required to demonstrate safety and effectiveness, but it can help ensure that benefit is
understood in the context in which patients will use the technology.

This reflects the Association’s broader position that predictability should result from clarity about
evidence expectations and meaningful patient outcomes, not from lower scientific standards or
unnecessary rigidity.

The ALS Association supports rigorous, risk-appropriate evidence standards grounded in real-world
use, representative patient experience, and meaningful patient outcomes.

Connected Technologies Should Preserve Patient Agency

As AI-enabled technologies become more capable and connected, FDA should consider what happens
when information generated or interpreted by one system becomes an input into another.

This issue could become particularly important for people living with ALS. An AI-enabled AAC or braincomputer interface (BCI) system could, for example, help an individual communicate pain, breathing
difficulty, or another change in condition. Communicating that information to clinicians or caregivers
could provide meaningful benefit. Communicating a clinical need, however, should not by itself
constitute authorization for another AI-enabled or connected medical device to alter treatment.

If an AI-generated or AI-interpreted communication could lead to a change in medication delivery,
ventilatory support, or another consequential aspect of care, FDA should consider safeguards
proportionate to the potential risk. These may include confirmation that the technology accurately
captured the patient’s intended communication, clear limits on device autonomy, and qualified clinical
review when clinical judgment is required.

Human oversight should likewise be meaningful and proportionate. Not every use of AI requires clinician
approval, and unnecessary requirements could reduce independence or delay beneficial uses of
technology. The need for oversight should increase as a system moves from helping a patient
communicate or providing information toward recommending or independently taking a consequential
clinical action.

Technology should amplify the voice and autonomy of a person living with ALS, not transfer decisionmaking authority from the patient to an algorithm or a network of connected devices.

Interoperability should not inadvertently transform an assistive technology designed to amplify a
patient’s communication into an autonomous clinical decision-maker.

Predictable Regulation Can Support Both Safety and Innovation

Rapidly evolving technologies require regulatory flexibility, but flexibility should be accompanied by clear
and predictable expectations.

FDA should provide opportunities for early engagement so that developers can understand the patient
input, performance measures, evidence, and safeguards appropriate to a proposed intended use.
Evidence expectations should be proportionate to risk and should evolve appropriately as a technology
assumes greater autonomy or more consequential functions. This does not require lower standards. It
requires clarity about what evidence is needed, what uncertainty remains, and how that uncertainty can
appropriately be addressed.

The Association has previously encouraged FDA to support early scientific engagement, predictable
regulatory pathways, patient-centered evidence, and clear expectations for emerging technologies.
These approaches can reduce uncertainty while maintaining FDA’s standards for safety and effectiveness.
An effective technology that becomes available only after an individual has lost the ability to benefit
from it may fail to realize its potential patient benefit.

Greater regulatory predictability benefits patients as well as innovators. For people living with rapidly
progressive diseases such as ALS, delays matter.

Patients Should Remain Part of the Total Product Lifecycle

The ALS Association supports a total product lifecycle approach to GenAI-enabled medical devices.

Because GenAI-enabled systems and the environments in which they operate may evolve, appropriate
postmarket evidence can complement premarket evaluation and help identify emerging problems in
real-world use.

Patients and caregivers should have accessible ways to report not only harmful outcomes, but also
recurring communication failures, accessibility problems, inappropriate escalation, failures to escalate,
or unintended interactions between connected technologies.
Greater reliance on postmarket evidence may be appropriate for some residual uncertainties. It should
not, however, substitute for necessary premarket evidence when a technology can independently take a
high-consequence clinical action or when an error may be difficult to identify before harm occurs.

Patient organizations can also help identify patterns across individual experiences and advise whether
emerging issues affect outcomes important to their communities. Their participation should
complement, not replace, the manufacturer’s responsibility for the safety, effectiveness, monitoring, and
appropriate correction of the regulated device.

The ALS Association supports a total product lifecycle approach that pairs appropriate premarket
safeguards with robust postmarket monitoring and patient input as GenAI-enabled medical devices
evolve.

Recommendations

The ALS Association appreciates FDA’s consideration of the regulatory challenges and opportunities
presented by GenAI-enabled medical devices.

For people living with ALS, these technologies may create meaningful opportunities to preserve
communication, independence, access to information, and participation in care. FDA has an opportunity
to establish a framework that supports these benefits while protecting patients from consequential
failures.

The Association encourages FDA to:

• base regulatory expectations on intended function, autonomy, and the potential consequences
of an incorrect output;

• engage patients early in defining meaningful performance and evidence needs;

• require rigorous, fit-for-purpose evidence that reflects intended users and realistic conditions of
use;

• preserve the distinction between communicating patient information and authorizing a
consequential clinical action;

• apply appropriate safeguards as AI-enabled technologies become more autonomous and
interconnected;

• provide clear and predictable regulatory expectations without unnecessary rigidity; and

• include patients and caregivers throughout the total product lifecycle.

Innovation should not require accepting unnecessary risk, and patient protection should not require
preventing responsible innovation. A patient-centered and scientifically rigorous framework can advance
both objectives.

For people living with ALS, the central principle should remain clear: AI-enabled technology should
amplify patient voice and autonomy. When a technology helps a patient communicate a need, that
communication should be understood accurately and treated with respect. When it could become the
basis for changing medication, respiratory support, or another consequential aspect of care, appropriate
safeguards should preserve the roles of the patient and qualified clinicians in making that decision.

On behalf of The ALS Association and the people living with ALS, caregivers, researchers, clinicians, and
advocates whom we represent, we appreciate the opportunity to provide these comments.

Please contact Rich Brennan, Vice President, Federal Affairs, at rich.brennan@als.org with any questions.

Sincerely,

Rich
Richard D. Brennan Jr., M.A.

Vice President, Federal Affairs
The ALS Association
1300 Wilson Boulevard, Suite 600
Arlington, VA 22209
www.als.org