FDA Consultation on the Electronic Submission Template for Premarket Approval Applications (PMAs)
Updated: Oct 12
On 18 September 2026, the U.S. Food and Drug Administration (FDA) issued draft guidance on the Electronic Submission Template for Premarket Approval Applications (PMAs). The draft describes FDA’s proposed approach to the electronic submission of specified PMA application and supplement types using the electronic Submission Template And Resource (eSTAR). When finalized, the guidance would establish electronic submission standards, an implementation timetable, and criteria for exemptions and waivers under section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Overview
Authority | U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) |
Date | 18 September 2026 |
Focus | eSTAR-based electronic submission requirements for specified PMA application and supplement types |
Type | Draft guidance for industry and FDA staff; request for comments |
Deadline for comments | 17 November 2026 |
What is this about?
FDA is continuing its implementation of electronic submission requirements for medical device premarket submissions under section 745A(b) of the FD&C Act. For the PMA submission types covered by the draft guidance, eSTAR is currently the only available electronic submission template and would be used to meet the electronic submission requirements described in the guidance following the proposed implementation period.
The draft applies to the following designated application types:
Original PMAs
Panel-Track Supplements
180-day Supplements
Real Time Supplements
30-Day Notices/135-Day Supplements
PMA Modules and Modular Shells are outside the current scope.
eSTAR is a structured, dynamic PDF that guides applicants through preparation of a submission using questions, prompts, logic, integrated databases and both structured and unstructured information. FDA has designed the PMA eSTAR structure to align closely with its internal Submission Memo And Review Template (SMART), supporting its broader objective of improving submission consistency and review efficiency.
Importantly, the proposal is not simply guidance on a voluntary submission tool. Once finalized and following the proposed transition period, the designated application types would generally be required to be submitted electronically in the specified format unless an exemption applies.
Consultation details
The draft guidance describes the proposed electronic submission framework in several key areas:
eSTAR structure and content: The template covers applicant and device information, regulatory interactions, indications for use, benefit-risk information, labeling, performance testing, software and cybersecurity information, Quality Management System Regulation (QMSR) information, post-market study plans and administrative documentation
Data standardization and review efficiency: FDA states that the structured format is intended to improve submission quality, facilitate technical screening and support more efficient and consistent review processes
Technical screening: FDA intends to use virus scanning and technical screening for PMA eSTAR submissions. For Original PMAs and Panel-Track Supplements, eSTAR submissions would be subject to technical screening rather than the existing refuse-to-accept (RTA) process. Screening is anticipated within 15 calendar days after receipt of the submission and payment of the applicable user fee
Incomplete submissions: If a submission fails technical screening, FDA intends to place it on hold pending additional information. Following resubmission, technical screening would be repeated and the review clock would restart at day 0
Exemptions and waivers: Certain submission types, reports and requests would be exempt from the requirements. FDA states that it has not currently identified circumstances in which a waiver would be appropriate for the designated application types
Implementation: FDA intends to provide a transition period of at least one year following issuance of the final guidance before electronic submission becomes mandatory for the designated application types
The draft also notes an important distinction regarding its legal effect. While FDA guidance is generally nonbinding, the provisions establishing standards, the implementation timetable, and criteria for waivers and exemptions under section 745A(b)(3) would have binding effect once the guidance is finalized.
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: 18 September 2026
Deadline for comments: 17 November 2026
Transition to required electronic submission: At least one year following issuance of the final guidance
Why this matters
The draft guidance would move specified PMA submission types toward a standardized electronic submission process based on eSTAR. For companies developing devices requiring PMA approval, this could affect submission preparation processes, document organization, internal quality checks and interactions with FDA during the initial stages of review.
The proposed technical screening process is particularly relevant. For Original PMAs and Panel-Track Supplements, FDA anticipates that eSTAR submissions would undergo technical screening rather than the existing RTA process. Companies may therefore need to adapt submission-readiness procedures to the structure and completeness checks embedded in eSTAR.
More broadly, the proposal reflects FDA’s continued move toward increasingly structured and standardized regulatory submissions. Stakeholders may wish to use the consultation period to raise practical implementation issues before FDA establishes its final approach.
Who should consider responding?
Medical device manufacturers preparing or planning PMA submissions
Holders of approved PMAs submitting supplements covered by the draft guidance
Regulatory affairs teams responsible for PMA submission preparation and lifecycle management
Submission operations and regulatory technology teams supporting eSTAR-based submissions
Industry associations representing manufacturers of PMA-regulated devices
Practical implications
Stakeholders should consider:
Reviewing whether current or planned PMA activities fall within the designated application types
Assessing whether existing PMA content, documentation workflows and quality controls align with the proposed eSTAR structure
Considering how the proposed technical screening process could affect submission-readiness checks and review timelines
Reviewing the proposed exemptions and FDA’s current position on waivers
Identifying operational or technical issues that may warrant comments before the 17 November 2026 deadline
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