On September 25, 2026, the Food and Drug Administration (FDA) issued draft guidance, "Robotically-Assisted Surgical Devices – Premarket Submissions." The document establishes the FDA's first comprehensive proposed framework specifically addressing premarket submissions for robotically assisted surgical devices.
The 50-page draft guidance goes well beyond a checklist of individual submission sections. It addresses device descriptions, predicate comparisons, risk analysis, verification and validation, nonclinical and clinical evidence, software, cybersecurity, training, human factors, and labeling.
Manufacturers should evaluate these interconnected workstreams together to ensure testing strategies, clinical study plans, training programs, and proposed labeling are aligned before development plans and protocols become difficult or costly to change.
Draft Guidance Focuses on Local Teleoperation
The FDA defines a robotically assisted surgical device (RASD) as a teleoperated, software-controlled system that uses a leader/follower architecture to assist a qualified practitioner control surgical instruments during open, minimally invasive, or endoluminal procedures.
The draft guidance focuses on local teleoperation, in which the operator console and bedside or patient subassembly are in the same operating room.
It excludes preoperative planning and stereotaxic systems, RASDs used for surgical tasks involving interventional devices, remote teleoperation, and autonomous robots that independently perform significant portions of procedures.
Some recommendations may still apply to excluded devices. The FDA strongly recommends using the Q-Submission Program for devices that fall, or may fall, outside the guidance’s scope.
FDA Calls for an Integrated, System-Level Evidence Package
The FDA recommends testing each subassembly, the full system, surgical instruments and cameras, and the system as used with accessories and compatible devices.
Testing should simulate representative and worst-case clinical conditions. Full reports should identify the objective, test methods and procedures, sample size, predefined pass/fail criteria and their relevant clinical justification, the rationale for the surgical instrument tested, results, and conclusions.
For latency, accuracy, repeatability, resolution, and workspace verification testing, the FDA recommends a sample size of at least three device units. Manufacturers proposing to test fewer than three device units should provide a rationale for the smaller sample size.
The FDA also recommends describing features intended to enhance or augment human capabilities in separate, feature-specific sections of the submission. Demonstrative videos may help explain device operation and key features.
The proposed testing program extends beyond basic robotic-arm accuracy and includes:
- Total system latency from console input to instrument motion and visual feedback.
- Motion scaling, tremor reduction, and other input-processing functions.
- System stability and fault management, including fault detection, response and recovery, safe emergency removal of the RASD from the patient, and emergency or safety stops under normal and fault conditions.
- Accuracy, repeatability, reachability, collision avoidance, singularity mitigation, velocity limits, and physical stability.
- Visualization and display performance.
- Compatibility with accessories and third-party devices.
For 510(k) submissions, the FDA recommends supplementing the detailed substantial-equivalence analysis with a high-level table summarizing key differences between the new RASD and its predicate device.
Reliability Testing May Require Significant Early Planning
The FDA recommends reliability testing across hardware, software, mechanical, and electrical components. Manufacturers should show that the system can maintain instrument control and essential surgical information over its service life.
Reusable instruments should be assessed over their labeled use life, including reprocessing. Reusable devices should undergo biocompatibility testing after the maximum number of use cycles.
For grip and cutting reliability, acceptance criteria should address required grip force and quantitative cutting performance. The FDA recommends clinically justified cycle counts, worst-case grip loading, and sufficient sample size to demonstrate 95% reliability with 95% confidence, unless another approach is justified.
These recommendations could affect design freeze, unit availability, protocol duration, labeling, and cost. Early alignment on service-life and use-life assumptions will therefore be important.
Clinical Evidence May Support Multiple Procedures
Clinical data are often needed for new RASDs. The FDA may also request clinical evidence for a modified system involving a new intended use, special populations, different technology, concerning nonclinical findings, or specific performance claims.
The agency generally considers investigations of RASDs addressed by the draft guidance to involve significant-risk devices. Those studies therefore would not qualify for the abbreviated investigational device exemption (IDE) requirements.
The draft guidance identifies nine commonly relevant endpoints: hospital stay, intraoperative adverse events, blood loss or transfusion, conversion, postoperative adverse events, readmission, reoperation, mortality, and operative time.
If premarket evidence leaves uncertainty about safety or effectiveness, the FDA may require postmarket clinical data addressing adverse events, patient populations, or other unresolved questions.
Umbrella and Covered Procedures
The proposed “umbrella and covered procedure” paradigm may be one of the draft guidance’s most significant features. The FDA describes the paradigm as “a least burdensome approach for developing the minimum amount of data necessary” to support authorization.
Under this approach, in vivo data from a sufficiently complex and higher-risk “umbrella procedure” could support authorization of a RASD for lower-complexity, lower-risk “covered procedures” within the same surgical specialty, without additional procedure-specific performance data.
Umbrella procedures generally should contain identical or very similar procedural steps to those in the associated covered procedures. They typically should fall within the same surgical specialty and may involve similar anatomic locations. The RASD’s benefit-risk profile for the umbrella procedure should be similar to or greater than its profile for covered procedures.
The draft guidance provides illustrative examples involving colorectal, gastric, hernia, general surgery, gynecologic, urologic, thoracic, and cardiac surgery. The FDA cautions, however, that there is no set list of appropriate umbrella and covered procedures and that relying on data from the examples will not always be appropriate.
A combination of umbrella and/or covered procedures could support authorization for an entire specialty or subspecialty. In the future, a single umbrella procedure may also cover more than one anatomical area or subspecialty.
The paradigm may support the addition of specified surgical procedures, but not other indication changes, such as claims for the treatment of a specific disease or condition.
Because the selection of umbrella procedures may affect study design, enrollment strategy, development costs, regulatory timelines, and the scope of an authorization, manufacturers should consider discussing proposed umbrella and covered procedure strategies with the FDA through the Q-Submission Program before finalizing their clinical development plans.
Software and Cybersecurity Expectations Are Extensive
The draft generally calls for Enhanced Documentation for RASD software under the FDA's "Content of Premarket Submissions for Device Software Functions" guidance. Enhanced Documentation applies when a software failure or flaw could create a hazardous situation involving a probable risk of death or serious injury before implementation of risk controls.
Compared with Basic Documentation, Enhanced Documentation includes additional materials such as detailed software design specifications, complete configuration-management and maintenance-plan documentation, and unit- and integration-level test protocols and reports. Manufacturers proposing Basic Documentation for an RASD should provide a scientific rationale based on the software functions’ risks and intended use.
In addition to the FDA’s generally applicable medical-device cybersecurity recommendations, the RASD draft guidance recommends that cybersecurity assessments, including penetration testing, address all network elements communicating with the RASD. These include the RASD’s subassemblies, accessories and compatible devices, public and private networks, remote access, teleoperation, system updates, and back-end infrastructure such as servers, databases, and cloud-based services.
The FDA also recommends simulations in which the RASD communicates with a compromised hospital network.
Advanced Features Need Separate Risk Assessments
For functions using artificial intelligence or machine learning (AI/ML), eye tracking, haptics, or additional imaging modalities, the FDA recommends feature-specific risk assessment and testing. Manufacturers should consider redundancy and fail-safe design for critical components. The agency recommends Q-Submission engagement for high-energy imaging or AI/ML-enabled features. A predetermined change control plan may also be appropriate for anticipated post-authorization software changes.
Training and Human Factors Should Cover the Full Surgical Team
Training and human factors should reflect the entire surgical health care team, not only the surgeon. The FDA recommends validated training for relevant user groups. Human-factors validation may need to include representative teams working simultaneously in a realistic operating room.
Sponsors should address negative transfer, instrument exchange, team communication, emergency procedures, power loss, optional features, and multiple system configurations.
Steps Manufacturers Can Take Now
Manufacturers developing, modifying, or preparing submissions for RASDs should evaluate the draft guidance against their regulatory and development strategy. Key steps include:
- Confirming scope and identifying issues for Q-Submission feedback.
- Conducting a cross-functional gap assessment covering device description, risk management, software, cybersecurity, testing, clinical evidence, training, human factors, reliability, reprocessing, and labeling.
- Reviewing protocols before execution for consistent worst-case conditions, procedures, configurations, sample sizes, acceptance criteria, and service-life assumptions.
- Evaluating whether an umbrella and covered procedure strategy supports the intended indications.
- Planning for software updates, AI modifications, accessories, instruments, additional procedures, training changes, and postmarket evidence needs.
Comments Are Due November 24
Comments on the draft guidance should reference Docket No. FDA-2026-N-9505 and be submitted by November 24, 2026 to ensure consideration before the FDA begins work on the final guidance.
The FDA will also hold a public workshop on December 2–3, 2026, addressing benefit-risk evaluation for robotic medical devices with autonomous or remote teleoperation capabilities.
Alston & Bird assists clients with comment strategy and submissions addressing regulatory, technical, and clinical issues. Our FDA: Drug & Device team also advises medtech companies on regulatory strategy, Q-Submissions, nonclinical and clinical development, and premarket submissions.
Please contact us for assistance assessing the draft guidance’s impact on an existing or planned robotic surgical platform.
If you have any questions, or would like additional information, please contact one of the attorneys on our FDA: Drug & Device team.
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