The U.S. Food and Drug Administration (FDA) has published a new discussion paper exploring how benefit-risk considerations could evolve for robotic medical devices with autonomous and remote teleoperation capabilities.
Published in November 2026, the document is intended to stimulate stakeholder discussion and gather early feedback on terminology, evidence, risk mitigation and potential future policy approaches for these rapidly evolving technologies.
Importantly, FDA makes clear that the paper is not draft or final guidance, does not establish regulatory expectations and does not itself propose policy changes.
Public Workshop Scheduled for December 2026
FDA’s Center for Devices and Radiological Health (CDRH) will also hold a hybrid public workshop on 2–3 December 2026 to discuss the topics raised in the paper.
The discussion is intended to support a broader multi-stakeholder conversation involving industry, healthcare professionals, patients and other interested parties.
Why FDA Is Looking at Robotic Device Systems
FDA notes that innovations in:
robotics;
artificial intelligence;
machine learning;
connectivity
are transforming the healthcare landscape and expanding the potential applications of robotic device systems.
Autonomy and remote teleoperation are identified as two particularly important areas of emerging innovation because they may introduce new and more complex benefit-risk considerations.
Scope Goes Beyond Robotic Surgery
The discussion paper is not limited to robotically-assisted surgical devices.
FDA’s scope includes robotic systems used for:
diagnostic tasks;
therapeutic tasks;
rehabilitation;
positioning;
imaging;
navigation;
open procedures;
minimally invasive procedures;
non-invasive procedures;
endoluminal procedures.
This broader scope reflects the increasing use of robotic technologies across multiple clinical settings.
Examples of Emerging Robotic Applications
FDA highlights several examples of technologies currently being explored by manufacturers.
These include:
remote robotic ultrasound;
remotely teleoperated surgical robotic systems;
autonomous peripheral blood collection;
robotic systems intended to autonomously identify and stop internal bleeding.
The examples illustrate how robotics could move beyond traditional surgeon-controlled systems.
FDA Proposes Working Definitions
To support discussion, FDA proposes definitions for several key concepts.
A robotic device system is described as an electromechanical system activated by deliberate user action to perform or assist diagnostic, therapeutic or rehabilitative tasks on human anatomy.
What FDA Means by Autonomy
FDA describes autonomy as the ability of a robotic device system to perform tasks and make decisions based on current state and sensing without user intervention.
Autonomy exists on a spectrum, ranging from systems where the user maintains complete control to potential future systems capable of fully autonomous procedures.
Autonomy Is Different from Automation
FDA also distinguishes autonomy from automaticity.
Automatic systems follow predictable programmed rules, while autonomous systems may adapt to changing conditions using broader planning, contextual information and decision-making capabilities.
The discussion paper focuses on autonomous rather than merely automated functions.
Levels of Autonomy
Several frameworks already exist to describe robotic autonomy.
FDA discusses the widely referenced Yang et al. framework, which ranges from:
Level 0 — full surgeon control;
through intermediate levels;
to Level 5 — fully autonomous surgery without user input.
The paper also references frameworks from IEC/TR 60601-4-1 and other academic approaches that divide autonomy into cognitive functions such as:
monitoring;
generating;
selecting;
executing.
Potential Benefits of Autonomous Robotic Systems
FDA identifies several potential benefits.
Autonomous capabilities may improve:
consistency;
repeatability;
procedural accuracy;
workflow efficiency;
patient outcomes;
access to care.
Autonomous functions may also reduce the physical or cognitive burden on healthcare professionals.
Role of AI and Machine Learning
AI and ML could further enhance autonomous robotic capabilities.
FDA notes potential applications such as:
real-time image recognition;
intraprocedural decision support;
adaptive planning;
patient-specific execution.
These technologies may allow robotic systems to respond to complex anatomical or procedural conditions in ways traditional rule-based automation cannot.
Autonomy Also Creates New Risks
The FDA identifies several potential risks associated with increasing autonomy.
These include:
incorrect autonomous execution;
reduced user vigilance;
limited adaptability;
delayed human intervention;
software failures;
communication failures;
automation bias;
difficulty overriding autonomous behaviour.
The severity of these risks may increase as greater decision-making responsibility shifts from the healthcare professional to the robotic system.
Failure to Adapt Could Cause Serious Harm
FDA notes that autonomous systems may encounter unexpected conditions such as:
tissue deformation;
bleeding;
unusual anatomy;
other intraprocedural changes.
Failure to adapt correctly could potentially lead to:
misdiagnosis;
uncontrolled bleeding;
injury to tissues or organs;
failure to achieve the intended clinical outcome.
Human Factors Remain Critical
Automation bias is specifically identified as a potential safety concern.
Users may over-rely on the robotic system instead of exercising independent clinical judgement.
Conversely, automation rejection could lead users to override appropriate autonomous decisions.
FDA therefore considers user training, learning curves and manual fallback capabilities important parts of the overall risk profile.
AI Performance May Vary Across Patients
AI- and ML-enabled autonomous systems create additional challenges.
FDA notes that algorithms may:
perform unpredictably outside their training distribution;
perform differently across patient subgroups;
lack transparency;
degrade over time as clinical conditions change.
These factors could potentially introduce disparities or unexpected failure modes.
Remote Teleoperation Defined
FDA defines remote teleoperation as real-time control of a robotic device system where the operator is not physically present in the room with the patient.
The distance could range from:
another room;
another hospital;
another geographic region;
another country.
Connectivity may use technologies such as:
fibre optic networks;
Wi-Fi;
5G;
satellite communication.
Remote Teleoperation Could Expand Access to Specialists
One of the most significant potential benefits is improved access to specialised healthcare.
FDA notes that remote teleoperation could connect patients in underserved or difficult-to-access locations with specialist clinicians.
This could be especially important for time-sensitive conditions such as:
ischaemic stroke;
myocardial infarction.
Remote Intervention Could Reduce Treatment Delays
For certain emergencies, faster access to a remote specialist could improve patient outcomes.
A clinician with specialised expertise could potentially operate a robotic device remotely where equivalent expertise is unavailable locally.
This could also support remote mentoring and proctoring.
Intraprocedural Emergency Management Is a Major Concern
Remote teleoperation also introduces serious challenges.
FDA highlights the possibility that adverse events may occur when the remote specialist is physically distant from the patient.
Examples include:
bleeding;
tissue trauma;
connectivity loss;
need for urgent conversion to local intervention.
In extreme cases, failure to manage such complications could result in death.
Local Expertise May Still Be Necessary
One possible mitigation is having qualified healthcare professionals available beside the patient.
However, FDA notes that this could create an important practical trade-off.
If both a remote specialist and an equally qualified local specialist are needed for the same procedure, the technology may not achieve its intended goal of expanding access to scarce expertise.
Connectivity Is Central to Safety
Remote teleoperation depends heavily on reliable communication.
FDA identifies risks related to:
audio-video communication loss;
motion-control latency;
degraded signals;
asynchronous communication;
interruption of real-time imaging.
These risks become particularly significant in critical procedures where even short delays may lead to severe patient harm.
Remote Users May Lose Important Sensory Information
An on-site clinician may rely on sensory information that is difficult to reproduce remotely.
FDA provides examples such as:
changes in drill sound;
tissue resistance;
procedural odours.
Potential mitigations could include:
haptic feedback;
visual alerts;
force limits;
velocity limits;
built-in safety boundaries.
Manual Conversion Must Be Considered
The paper raises questions regarding how quickly a remotely performed procedure can be converted to manual local intervention if necessary.
Relevant factors include:
availability of local personnel;
required level of clinical expertise;
time needed to escalate care;
whether patient transfer would be required.
FDA notes an important paradox: areas that could benefit most from remote teleoperation may also have the fewest resources available to manage emergencies.
Combining Autonomy and Remote Teleoperation Could Compound Risk
Systems incorporating both autonomous and remote capabilities may introduce risks beyond those associated with either function alone.
FDA identifies examples such as:
latency during emergency human intervention;
unreliable transitions between autonomous and remote modes;
failure during handoff of control.
Sensor and Imaging Dependence
Both autonomous and remote systems may depend heavily on continuous sensor and imaging data.
Any degradation or failure in those inputs could compromise:
autonomous decision-making;
remote situational awareness;
overall patient safety.
Cybersecurity Is a Major Regulatory Consideration
FDA dedicates specific attention to cybersecurity.
Because robotic systems may depend heavily on network connectivity, a cybersecurity incident could compromise both autonomous decision-making and remote user control.
Potential impacts include loss of:
system integrity;
availability;
command accuracy;
sensor information;
patient safety.
End-to-End Cybersecurity Matters
FDA highlights several cybersecurity considerations:
network performance;
system-level threats;
integrity and non-repudiation;
availability;
reliance on users.
The paper emphasises that cybersecurity should be assessed from an end-to-end system perspective, since a vulnerability in one component could affect the entire robotic system.
Verification and Validation
Potential risk mitigations include robust verification and validation.
FDA is considering combinations of:
bench testing;
in silico testing;
cadaver studies;
clinical studies.
Testing should demonstrate that the robotic system performs appropriately across both normal and worst-case scenarios.
User Oversight and Emergency Controls
Even as systems become increasingly autonomous, human oversight may remain essential.
Healthcare teams may need training to:
perform manual overrides;
initiate emergency stops;
prepare the robotic system;
manage procedural spaces;
respond to failures.
Human Factors and Usability Engineering
FDA also highlights the potential role of human factors engineering.
Important areas may include:
user interface design;
transitions of control;
training;
Instructions for Use;
defined indications;
limitations.
Postmarket Oversight
Postmarket monitoring may become particularly important for these technologies.
FDA notes that:
real-world data;
Medical Device Reporting;
adverse event monitoring
could help identify problems involving autonomous or remote functionality after market authorization.
FDA Asks 15 Questions
Throughout the paper, FDA poses 15 discussion questions to stakeholders.
These address topics including:
terminology;
autonomy levels;
benefit-risk factors;
evidence requirements;
remote intervention;
emergency management;
connectivity;
cybersecurity;
verification and validation;
human oversight;
postmarket surveillance.
No Fully Autonomous or Remote Robotic Systems Authorized Yet
FDA notes that, as of July 2026, no fully autonomous or remotely teleoperated robotic device systems had received marketing authorization in the United States.
This makes the discussion particularly important as manufacturers increasingly explore these capabilities.
Impact on Manufacturers
For manufacturers developing advanced robotic medical devices, the paper highlights several areas that may become increasingly important:
clearly defining autonomy levels;
documenting user responsibilities;
establishing safe override mechanisms;
validating worst-case conditions;
evaluating network performance;
assessing cybersecurity;
demonstrating reliable control transitions;
defining local emergency support;
collecting clinical and non-clinical evidence;
establishing postmarket monitoring plans.
Early Signal for Future Regulatory Policy
Although this is not formal guidance, the discussion paper provides an important indication of the regulatory questions FDA is actively exploring.
Manufacturers working on autonomous or remotely operated robotic systems should therefore monitor the consultation closely and consider how their development programmes address the concerns highlighted by the Agency.
FDA Seeks Stakeholder Input
FDA states that stakeholder feedback will help inform future policies related to robotic device systems with autonomous or remote teleoperation capabilities.
The Agency aims to develop a regulatory approach capable of appropriately mitigating risks while supporting the meaningful benefits these technologies may offer.
