USFDA Draft Guidance: Electronic Submission Template for Premarket Approval Applications (PMA) and Updates for Medical Device Submissions: Robotically-Assisted Surgical Devices
The FDA has issued two draft guidances in September 2026 covering important aspects of medical device regulatory submissions. One focuses on premarket submissions for robotically-assisted surgical devices (RASDs), while the other provides recommendations for the electronic submission of Premarket Approval (PMA) applications using the eSTAR template.
These guidances highlight FDA's focus on structured technical evidence, software and cybersecurity considerations, clinical and non-clinical performance, and greater use of electronic submission processes.
The draft guidance provides recommendations for premarket submissions for certain robotically-assisted surgical devices. These devices are generally teleoperated, software-controlled systems that combine robotic technologies to help qualified practitioners position and control surgical instruments during procedures.
Scope of the Guidance
The guidance covers certain RASDs used for open, minimally invasive, and endoluminal procedures. It does not specifically cover pre-operative planning systems, stereotaxic systems, remotely teleoperated RASDs, or autonomous robots that independently perform significant aspects of surgical procedures. Manufacturers with devices outside the defined scope are encouraged to engage with FDA through the Q-Submission Program.
Device Description and Predicate Comparison
Manufacturers should provide a clear description of the complete RASD, including its major components, operating principles, system architecture, connections, data transmission, and relevant physical characteristics. For 510(k) submissions, information supporting the predicate comparison should also be provided.
Non-Clinical Performance Testing
The guidance provides recommendations for RASD-specific performance testing. Areas include teleoperation, system controls, kinematics and dynamics, visualization and display systems, additional robotic features, and reliability. These evaluations are intended to demonstrate that the device performs safely and effectively under its intended conditions of use.
Teleoperation, Controls and Kinematics
Because RASDs depend heavily on interaction between the practitioner and robotic system, FDA recommends addressing aspects such as control mechanisms, system response, movement, force, range of motion, and potential limitations associated with robotic configurations. Teleoperation characteristics and system performance should be appropriately evaluated.
Software and Cybersecurity
Software is an important component of RASDs. The guidance addresses software functions, cybersecurity, wireless technology, and related system considerations. Manufacturers should provide appropriate information to demonstrate that software-controlled functions operate as intended and that relevant cybersecurity risks have been addressed.
Training and Human Factors
The guidance also addresses training and human factors. Manufacturers should consider the knowledge and skills required for users to operate the device safely and effectively, including appropriate training related to system operation and relevant device features.
Overall, the draft guidance provides a structured framework for addressing the technical, clinical, software, cybersecurity, usability, and safety aspects of RASDs within premarket submissions.
The second draft guidance focuses on the electronic submission of Premarket Approval applications and certain PMA supplements using FDA's electronic submission template, known as eSTAR. The objective is to support more consistent and structured submissions and facilitate FDA's review process.
Purpose of eSTAR
eSTAR is designed as an interactive electronic submission template that guides applicants through the information required for a PMA submission. It uses questions, prompts, and structured sections to help applicants provide the necessary information and supporting documents.
PMA Submission Structure
The template covers key areas such as applicant information, previous regulatory interactions, device description, indications for use, market history, benefits and risks, labeling, reprocessing, sterility, biocompatibility, software, cybersecurity, interoperability, safety testing, performance testing, quality management system information, post-market study plans, references, and administrative documentation.
Technical Screening and Review
FDA intends to conduct technical screening of PMA eSTAR submissions. For PMAs and PMA supplements, the technical screening is anticipated to occur within 15 calendar days after FDA receives the submission. If required information is incomplete, the applicant will be notified and the submission may remain on hold until the necessary information is provided. Once the submission passes technical screening, it can proceed to substantive review.
Electronic Submission Requirements
Following finalization and implementation, designated application types are expected to be submitted electronically unless an applicable exemption applies. FDA intends to provide a transition period of at least one year following final guidance issuance before electronic submissions become required. During the transition period, eSTAR may be used voluntarily.
Exemptions and Waivers
The draft identifies certain submissions and activities that may be exempt from the electronic submission requirements. These include interactive review responses, certain amendments, appeals or supervisory review requests, substantive summary requests, withdrawal requests, annual or periodic reports, and post-approval study reports. At present, FDA has not identified specific circumstances for granting waivers.
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