What roles should clinicians and institutions play in monitoring, without diluting manufacturer accountability?

R2. Do not trade premarket evidence for postmarket monitoring outside the lowest-risk quadrant (Questions 18, 19, and 21) This follows from S1 and S2. Question 18 asks whether CDRH should "accept greater premarket uncertainty regarding a GenAI-enabled device's benefit-risk profile through greater reliance on postmarket monitoring." My answer is a qualified no. The framework in S1 exists precisely to identify which functions can tolerate uncertainty. If a function sits in the lower-left quadrant — non-directive information with limited consequences — then reduced premarket evidence with defined monitoring is a reasonable proportionality judgment. For anything action-directing or action-taking, or anything with moderate or severe consequences, accepting premarket uncertainty transfers risk from the sponsor, who chose to deploy, to the patient, who did not. Docket No. FDA-2026-N-7874 — Individual comment — Page 3 Postmarket surveillance is also structurally weaker than the paper implies. Existing device adverse event reporting depends on passive reporting and is known to under-capture harm. GenAI failure modes — confabulation, cumulative scope drift, over-reassurance, silent degradation after an upstream model change — have no established reporting taxonomy, no established detection method, and no natural reporter, since the patient may never learn that an output was wrong. Before postmarket monitoring can justify reduced premarket evidence, CDRH would need at least the following in place: a reporting taxonomy specific to GenAI failure modes; prespecified, publicly disclosed performance thresholds with a defined cadence of re-benchmarking; a patient-facing channel for reporting suspected incorrect outputs; and public reporting of monitoring results, not just submission to FDA. On Question 21, I would caution against "shared ecosystem responsibility" becoming a mechanism for diffusing accountability. Clinicians, institutions, and professional societies can contribute signal. They should not absorb liability. The sponsor is the manufacturer and remains responsible for the device's performance across the total product life cycle, including for the behavior of components it licenses from others.

3. Question 21: Responsibility and intervention FDA identifies manufacturers as responsible for postmarket monitoring. [1, p. 20] I recommend that the manufacturer document the roles of deploying institutions and suppliers while retaining responsibility for its monitoring and response plan. The plan should assign responsibility for investigation, clinical assessment, restricting functionality, communication, and restoration. It should identify who makes each decision and who can implement it. The parties should demonstrate that they can complete any cross-organizational handoff within the response time justified for the hazard. Institutions can contribute workflow information and incident reports. Qualified clinicians can assess outputs and consequences; professional societies and standards-setting bodies can support evaluation methods. Manufacturers and institutions should agree on the staffing, access, and workload required for those contributions. They should provide users and affected patients with a practical route to report concerns and connect those reports to existing incident-handling processes. Manufacturers should select interventions suited to the device: disabling a tool, restricting writes, adding an approval step, or transferring work to an evaluated alternative. The plan should account for interruption risks and the institution's access controls. It need not grant manufacturers unrestricted remote access or require a universal shutdown mechanism. The parties should rehearse the relevant procedures before deployment and after changes that affect them. Exercises should cover unavailable decision-makers, supplier delays, and failure of the primary intervention mechanism. The responsible party should verify specified restoration criteria before resuming affected functionality. NIST recommends assigning and rehearsing incident- response responsibilities for third-party AI dependencies. [3, GV-6.2-003] 4. Questions 22 and 24: Device changes and supplier updates Question 22: Assess the effect of a change Manufacturers should assess changes across the deployed configuration, including model identifiers, instructions, retrieval rules, data transformations, tools, permissions, approval requirements, and execution logic. A versioned record should connect that configuration to its supporting evaluations. Manufacturers may use targeted testing when they can show which functions and safety properties a change could affect and why others remain unaffected. They should broaden evaluation for changes to shared dependencies or critical controls, or where interactions are uncertain. They should assess cumulative changes and add tests for failure modes the original benchmark did not cover. Brandon Kaplan | Individual capacity Page 3 of 6 PUBLIC COMMENT | FDA-2026-N-7874 For example, a developer might change laboratory-result selection from specimen-collection date to record-import date. An older result imported later could then displace a newer result. The model version would remain unchanged, but the manufacturer would need to test the selection rule and affected workflows. Manufacturers should distinguish ordinary patient inputs within the evaluated design from changes to the device's knowledge or behavior. Revised reference material, persistent memory reused across tasks, adaptive retrieval, or learning during operation may change later outputs. Manufacturers should define and evaluate the permitted scope of that adaptation, retain relevant provenance, and specify reassessment triggers. This approach does not require a separate release review for each incoming patient record. FDA's predetermined change control plan (PCCP) guidance links planned modifications to validation methods and impact assessment. [4, Sections V.D and VI-VIII] I recommend using that structure where applicable. A manufacturer should establish that a change falls within the authorized PCCP and follows its protocol before relying on that authorization. Regression tests alone cannot determine whether the manufacturer needs a new marketing submission. Question 24: Manage supplier changes and retirement Manufacturers should document the version guarantees, change notices, evaluation opportunities, and retirement arrangements their suppliers provide. A service identifier may cover less than the full configuration that affects behavior; the manufacturer should establish what it covers and which changes a supplier can make without changing it. The manufacturer should make adoption of a replacement an explicit release decision where version selection is available. For services that do not permit deferral, it should demonstrate how its controls manage change-related uncertainty within the response time required for safety. It should restrict the affected capability or choose a different dependency if those controls cannot support the intended use. Behavioral checks can help detect a change. Manufacturers should state their coverage and the failure

Question 21: Stakeholder roles The manufacturer must remain accountable for the marketed device. The manufacturer must manage monitoring, investigation, corrective action, reporting, model dependencies, and change control. The healthcare organization must manage local data, integration, workflow, access, training, and incident escalation. Clinicians should report and review possible errors. They should not be the only monitoring method. Newton’s Tree Inc Considerations for the Regulation of Generative AI-Enabled Medical Devices FDA Docket No. FDA-2026-N-7874 Professional societies can define specialist hazards, clinical measures, and reviewer qualifications. Standards bodies can define common formats for logs, versions, incidents, and performance measures. FDA can support a confidential multi-site monitoring network. This network can find rare signals that one manufacturer or hospital cannot find. The Newton’s Tree disagreement example also supports shared review. Approximately half of the reviewed outliers came from the human reference or workflow.

Question 21 (stakeholder roles without diffusing accountability). I recommend a two-signature release. The surgeon confirms anatomy, indication, and clinical intent; a qualified release authority within the manufacturer of record confirms conformance using design checks, process data, and inspection results. Neither signature substitutes for the other. This keeps accountability with the manufacturer—which, for point-of-care systems, is the institution holding the clearance—while making the clinician’s responsibility explicit and bounded rather than treating visual review as proof of properties Comment on Docket No. FDA-2026-N-7874 — Page 2 it cannot reveal. Institutions and registries can then support surveillance that links revisions, imaging follow-up, and adverse events to the model, design, and manufacturing configuration in use.

Discussion Question 21 – Roles and Stakeholders I agree that clinicians, healthcare institutions, professional societies, standards organizations, and other stakeholders may provide important information for postmarket monitoring, particularly regarding real-world workflows, emerging clinical practice, user behavior, and clinical outcomes. However, distributed data collection should not result in distributed accountability. The manufacturer should remain responsible for defining the monitoring strategy, integrating relevant information from the ecosystem, and implementing necessary corrective or preventive actions. Healthcare institutions may have an especially important role in identifying changes in the deployment environment, including workflow modifications, local protocols, user qualifications, and changes in the extent or effectiveness of human oversight. The associated interfaces and responsibilities should be clearly defined, including through appropriate agreements where applicable. Professional societies may contribute to identifying changes in clinical standards, guidelines, and appropriate reference standards. For higher-criticality applications, structured mechanisms for information exchange between manufacturers and deploying institutions may therefore be appropriate.

Question 21 Healthcare institutions can realistically contribute to post-market monitoring in three ways: maintaining an inventory of deployed AI-enabled device functions, retaining interaction and version logs where the manufacturer supplies them, and reliably reporting observed failures through existing safety channels. Each of these depends on manufacturers providing information institutions cannot generate themselves. Structuring the institutional role around receiving and reporting, rather than around independent evaluation would keep accountability with the manufacturer while making the institutional contribution achievable across the full range of U.S. health systems rather than only the best-resourced ones. Summary of recommendations 1. Structure the institutional role in post-market monitoring around receiving and reporting rather than independent evaluation so that adoption is achievable across the full range of U.S. health systems. 2. Where a monitoring framework assigns responsibilities to deploying institutions, specify what information manufacturers must supply to them since institutions cannot generate this information themselves. Examples include device version identifiers, interaction logs, and real-time notification of material model changes and their downstream effects. 3. Consider a tiered structure for Foundation Model Master Files, in which a defined subset of information is public while competitively sensitive content remains confidential, to enable independent scrutiny alongside FDA review CDRH’s post-market approach presumes an observational capability at the institutional level that does not presently exist in most U.S. health systems. Designing around that reality, rather than around the capability a well-resourced academic medical center might build, will produce a framework that functions where most patients actually continue to receive the best possible care in a safe, timely, and efficient manner. Thank you for the opportunity to comment. Chirag Kanitkar, MS, CSSGB Research reference: https://dx.doi.org/10.2139/ssrn.7278738

Question 21 - Roles of institutions, clinicians, and other stakeholders without diffusing manufacturer accountability Shared ecosystem responsibility should be translated into defined technical control responsibilities rather than treated as undifferentiated shared accountability. Manufacturers remain responsible for their devices, but other stakeholders control clinically relevant variables that manufacturers may not control directly. Examples include healthcare institutions controlling identity infrastructure, local permissions, policies, workflows, deployment configuration, and some clinical context; clinicians controlling professional judgment and intended human review; foundation-model providers 11 controlling model updates and certain model behaviors; and standards organizations influencing interoperable evidence and audit formats. For each material state variable, the assurance plan should identify who controls it, who may change it, who monitors it, how changes are communicated, and who has authority at a consequential execution boundary. This preserves manufacturer accountability while making ecosystem dependencies operationally visible. Allocation of control responsibility should improve attribution, monitoring, and corrective action; it should not operate as a mechanism by which a manufacturer disclaims responsibility for dependencies that are reasonably foreseeable components of the device's intended deployment.

Question 21 — Sharing responsibility without weakening accountability Shared responsibility should never become shared ambiguity. Manufacturer, healthcare institution, treating clinician, foundation-model provider, professional society, independent evaluator, and FDA each hold a distinct, assignable role — but the manufacturer retains primary accountability for the marketed device's clinical behavior. Neither “the hospital used it wrong” nor “FDA cleared it” should end the conversation about who is responsible.

Question 21 asks what roles standards-setting bodies and other stakeholders might play in postmarket monitoring, and how those roles can be structured without diffusing manufacturer accountability. The properties in Section 4 are semantic properties of an interoperability format. They cannot be established by any single manufacturer, because audit records cross organizational boundaries. A health information exchange, an electronic health record vendor, a payer, and a federal investigator all read records produced by systems they do not control. A manufacturer-specific attribution scheme reproduces the current problem in a proprietary shape and adds a translation burden. This argues for the standards-setting body role being specifically the definition of attribution semantics, with manufacturer accountability preserved intact. The manufacturer remains responsible for what its device does and for what its device emits. The standard determines only whether the emitted record is capable of expressing what happened. I would note one practical asymmetry. Small and under-resourced provider organizations, including community mental health centers, federally qualified health centers, and behavioral health programs, carry the same obligations as large health systems but cannot build audit infrastructure independently. If attribution semantics are settled in an open standard, those organizations inherit the capability. If they are settled per vendor, those organizations receive whatever their vendor supplies and are least able to evaluate it. 6. Response to Question 19: what postmarket degradation monitoring requires

Question 21. Shared ecosystem participation should enrich evidence without diffusing manufacturer accountability. Clinicians, healthcare institutions, professional societies, model providers, and standards bodies can contribute signals, adjudication, benchmarks, and deployment context. The manufacturer should remain responsible for aggregation, triage, risk decisions, corrective action, and regulatory reporting. Data-sharing agreements should specify provenance, timeliness, minimum fields, privacy protections, and feedback closure. FDA should recognize that safety-relevant information may cross hospital, cloud, model- provider, manufacturer, and device boundaries. Each consequential exchange should preserve sender and recipient identity, permitted purpose, patient or device scope, schema and clinical meaning, source and transformation provenance, applicable AI-SBOM configuration, integrity and freshness, privacy classification, retention, and onward-use restrictions. Transport encryption is necessary but does not establish that the sender was authorized, the information was semantically valid, or the recipient may use it for the proposed purpose. FDA should specify the required evidence properties rather than prescribe one privacy technology. Depending on the use case, sponsors may use local or federated evaluation, aggregation, pseudonymization, confidential computing, secure multiparty computation, homomorphic encryption, differential privacy, selective disclosure, or protected case-level access. Advanced cryptography should be treated as an optional implementation mechanism, not a prerequisite for compliance.

Question 21 Roles of clinicians, institutions and professional societies Manufacturer accountability need not be diffused if the roles are separated by function rather than shared over the same function. Professional societies appear to me well placed to hold something manufacturers cannot hold without conflict, and regulators are not resourced to build shared calibration materials and standardised case libraries for adjudicator training. The object being standardised there is reviewer judgment, not device performance, and it is common infrastructure rather than a competitive asset. Societies also already convene the clinical specialties whose judgment adjudication depends on. Healthcare institutions are best placed to own the reporting pathway ensuring a clinician who observes a problematic output has a defined route to report it that does not depend on individual initiative or on knowing who the manufacturer is. Under-reporting in drug safety is driven less by unwillingness than by friction, and the same is likely to hold here. Manufacturers should retain responsibility for the monitoring programme, its detection claims, and its verification. Societies calibrating reviewers and institutions carrying reports does not dilute that; it supplies conditions the manufacturer cannot create alone.

Question 21 — What roles should manufacturers, clinicians, hospitals, and other parties play without diffusing accountability? Response FDA identifies exactly the right concern in asking how responsibility may be shared without diffusing manufacturer accountability. The foundational principle should be simple: Shared responsibility must never become unowned responsibility. Every organization exercising meaningful authority, control, or influence should remain accountable for the portion of the system it controls. A manufacturer remains accountable for the performance and foreseeable failure modes of its technology. A hospital, health plan, employer, benefits platform, pharmacy, navigation company, utilization- management organization, or other deploying organization remains accountable for deciding to place that technology into a particular workflow and for the governance of its use. A clinician remains professionally accountable where the clinician is truly exercising clinical judgment. A foundation-model provider remains accountable for the representations it makes about the underlying technology. Third-party vendors remain accountable for their functions. Patients should not be made responsible for discovering failures that professionals and organizations deploying the system were better positioned to prevent. Accountability also requires reconstructability. For consequential healthcare interactions, the responsible organization should not later be able to say, “We do not know what the AI told the patient.” If AI said it, AI should be able to account for it. At minimum, consequential interactions should preserve what the person communicated, what relevant information the AI possessed at the time, what the AI said or did, what evidence materially informed the response, which system and model version generated it, what uncertainty or warnings were communicated, whether escalation occurred, and what later information materially changed the advice. This does not mean every casual AI exchange belongs in a medical, employment, or insurance record; privacy, consent, retention, and access are separate governance questions. Contracts can allocate tasks. They should not erase accountability. You can contract away a function. You cannot contract away accountability. This is increasingly important because healthcare AI is rarely a single product supplied by a single entity. The chain may include:  a foundation-model developer;  an application developer;  a data vendor;  an evidence-content vendor;  a health plan; Deborah “Nurse Deb” Ault | Response to FDA Discussion Paper | Page 15 FDA-2026-N-7874 | Generative AI-Enabled Medical Devices  a utilization-management company;  a TPA;  a PBM;  an employer;  a navigation vendor;  a health system;  clinicians;  and downstream subcontractors. After an adverse patient event, regulators should never discover that everyone involved can credibly say: “That part belonged to somebody else.” Accountability should follow authority, control, and influence.

Question 21 — Ecosystem roles and manufacturer accountability The accountability principle can be stated simply, and I recommend CDRH state it: information may come from anywhere; the duty to investigate and act remains with the manufacturer. Clinicians, institutions, and societies can be valuable sources of signal, and health systems in particular hold the outcome data manufacturers lack. But a manufacturer that has arranged to receive signal from third parties has not thereby delegated any portion of its complaint-handling, investigation, or reporting obligations, and the paper should say so directly to prevent the shared-ecosystem framing from being read as shared responsibility. I recommend building on the existing complaint-handling and MDR architecture rather than creating a parallel structure. That said, I want to flag a gap that I believe requires attention before postmarket monitoring can function at all for these devices: It is currently unclear what constitutes a reportable event for a generative output. If a device produces a clinically incorrect recommendation and the clinician recognizes and disregards it, has a device malfunction occurred? Under a conventional reading, the device did not perform as intended, and a malfunction that could cause or contribute to serious injury if it recurred is reportable — which would imply that hallucinations 13 of 19 Docket No. FDA-2026-N-7874 caught by users are reportable events. I do not believe manufacturers are currently operating on that reading, and I do not believe the volume would be manageable if they did. But the alternative reading — that only outputs resulting in actual harm are reportable — discards precisely the near-miss data that would make postmarket monitoring effective, and near-miss data is the most valuable signal any surveillance system collects. This ambiguity is consequential and unresolved, and every element of Section VI depends on how it is settled. I recommend CDRH address it directly, and would suggest that the workable answer likely involves a distinct, aggregate reporting channel for caught errors — reported as rates rather than as individual MDRs — so that the signal is preserved without generating unmanageable individual-event volume.

Question 21. Health plans as a postmarket monitoring participant The paper lists payers among ecosystem stakeholders without describing a role for them. We suggest a specific one. Medicaid and Medicare Advantage plans already audit completed assessments, already run inter- rater reliability checks across their assessor workforces, and already hold the downstream utilization and outcome data needed to determine whether an assessment output was correct. They have contractual access to the deployment environment, regulatory obligations of their own, and a direct financial interest in accuracy. Much of the monitoring capability CDRH is asking manufacturers to build already exists inside health plans. A workable structure preserves manufacturer accountability while using this capacity. The manufacturer defines the monitoring specification, the sampling frame, and the degradation thresholds, and remains responsible for detecting and reporting degradation. The plan supplies the sample and the outcome linkage under contract. This avoids duplicating an audit infrastructure already funded and already operating, and it produces monitoring data drawn from the actual deployment environment rather than from a manufacturer-selected sample. 1 3 Centers for Medicare and Medicaid Services, Payment Error Rate Measurement program, fiscal year 2025 results. The Medicaid improper payment rate was 6.12 percent, or $37.39 billion, and 77.2 percent of improper payments resulted from insufficient documentation or missing administrative steps. © 2026 Cara AI, Inc. Closing We appreciate the opportunity to comment and would welcome the chance to discuss the in-home and long-term services and supports setting with CDRH staff in more detail. Renee Dua, MD Founder and Chief Executive Officer, Cara AI, Inc. 8349 Reseda Boulevard, Suite G, Northridge, California 91324 renee@askcara.ai trycara.com © 2026 Cara AI, Inc.

FDA Question 21 - Shared ecosystem roles without diffusing accountability Trace ID. TR-Q21 | FDA Q21; Sec. VI.D; App. B; pp. 21-22 / 29-30 BCR response. Distribute evidence generation, not accountability. The manufacturer should retain the master residual/closure ledger; clinicians/institutions supply witnesses, societies supply clinical standards, and standards bodies support interoperable evidence structures. BCR rule basis. BCR-R02,R04,R09,R13,R17 Solution-stack link. S12,S13 Closure evidence. Master residual ledger with named accountable owner; external contributors provide traceable witnesses Pass / re-open. Every residual has one accountable owner despite distributed evidence generation Re-open when: Stakeholder responsibility/process change.

Response to Question 21: Stakeholder Accountability — Codify Roles to Prevent Diffusion Postmarket monitoring is inherently a multi-stakeholder activity, but accountability diffusion is a predictable consequence of undefined responsibilities. When everyone is theoretically responsible, no one is operationally responsible. FDA should codify the postmarket monitoring responsibilities of each stakeholder class in its final guidance. Specifically: healthcare institutions — hospitals, integrated delivery networks, ambulatory surgery centers — should bear responsibility for local workflow monitoring, user- facing adverse event detection, and institutional adverse event reporting. Professional societies should develop and maintain domain-specific performance standards and should provide expert review for MDR adjudication in their clinical domains. Foundation model developers should bear responsibility for proactive disclosure of model changes and known failure modes. Device manufacturers should retain primary reporting and remediation obligations. FDA should establish clear reporting pathways for each stakeholder class, including electronic submission standards and timeline requirements.