FDA Consultation on Robotically-Assisted Surgical Devices – Premarket Submissions
Updated: Oct 12
On 25 September 2026, the U.S. Food and Drug Administration (FDA) issued draft guidance on Robotically-Assisted Surgical Devices – Premarket Submissions. The draft provides recommendations on premarket submission content, non-clinical testing, clinical evidence and labeling for certain robotically-assisted surgical devices (RASDs). It is intended to promote greater consistency in the information provided to FDA and facilitate the review of these complex systems.
Overview
Authority | U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) |
Date | 25 September 2026 |
Focus | Premarket submission content, performance testing, clinical evidence and labeling for certain robotically-assisted surgical devices |
Type | Draft guidance for industry and FDA staff; request for comments |
Deadline for comments | 24 November 2026 |
What is this about?
The draft guidance addresses robotically-assisted surgical devices (RASDs), which FDA describes as teleoperated, software-controlled systems that assist qualified practitioners in positioning and controlling surgical instruments during open, minimally invasive or endoluminal procedures.
The scope does not include pre-operative planning or stereotaxic systems. It also excludes remotely teleoperated RASDs and autonomous robots that perform significant aspects of operative procedures independently of qualified practitioners, although FDA notes that some recommendations may still be relevant to these technologies.
The guidance is a draft and is not currently for implementation. If finalized, it will represent FDA's current thinking and will contain non-binding recommendations rather than legally enforceable requirements.
Consultation details
The draft provides recommendations across the RASD premarket submission and evidence package, including:
Device description and 510(k) comparisons: Detailed information on the RASD, its components, accessories, interfaces and relevant technological differences from predicate devices
Performance and reliability testing: RASD-specific testing of system control, movement, visualization, safety functions and overall system reliability
Software, cybersecurity, human factors and training: Expectations for software validation, cybersecurity risk management, usability and training programs
In vivo and clinical evidence: A stepwise approach to determining when non-clinical or clinical in vivo data may be needed
Umbrella and covered procedure paradigm: A proposed approach that may allow data from a higher-complexity procedure to support lower-complexity procedures within the same surgical specialty
The guidance also addresses additional safety, performance and labeling considerations, including electrical safety, sterility, reprocessing, biocompatibility and packaging.
Useful links
Access the official materials and submit your comments.
Announcement and overview
Full source document
Go to the official comment submission page
Key timeline
Publication: 25 September 2026
Deadline for comments: 24 November 2026
Why this matters
The draft guidance brings together FDA's proposed expectations for the premarket assessment of RASDs and highlights the importance of evaluating these devices as integrated systems, including robotic control, software, cybersecurity, instruments, human factors and training.
The proposed umbrella and covered procedure paradigm may be particularly relevant for evidence-generation strategies. Where applicable, it could allow manufacturers to leverage data from appropriately selected higher-complexity procedures to support additional, lower-complexity uses.
Manufacturers developing new RASDs or planning significant changes to existing systems may therefore wish to assess how the proposed recommendations align with current development, testing and submission strategies and whether practical issues warrant comment before the guidance is finalized.
Who should consider responding?
Manufacturers and developers of robotically-assisted surgical devices
Regulatory affairs teams responsible for RASD premarket submissions
Engineering, software, cybersecurity, human factors and clinical teams involved in RASD development
Organizations developing instruments, accessories or compatible technologies for RASDs
Professional and industry associations
Practical implications
Stakeholders should consider:
Determining whether current or planned robotic surgical systems fall within scope
Comparing existing verification, validation and reliability testing strategies with FDA's recommendations
Reviewing software, cybersecurity, human factors and training documentation against the proposed approach
Assessing how current evidence strategies align with FDA's proposed approach to in vivo evaluation
Identifying technical or operational recommendations that may warrant clarification or stakeholder feedback
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