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We have a breakdown for the device professionals among us. On September 18, 2026, CDRH and CBER issued a draft guidance titled Electronic Submission Template for Premarket Approval Applications (PMA).
If and when it’s finalized and implemented, it would require specified PMA submission types to be submitted electronically using FDA’s electronic submission template. eSTAR, the structured dynamic PDF, is currently the only template available for these submissions.
eSTAR has been mandatory for 510(k) submissions (unless exempted) since October 1, 2023, and for De Novo submissions, unless exempted, since October 1, 2025. PMAs can use it today on a voluntary basis. This draft sets up the requirement.
Comments are due within 60 days of the Federal Register notice announcing the draft. The docket number will appear in that notice.
Again, this is just a draft guidance right now.
Who and what this covers
The draft applies to five “Designated Application Types”: Original PMAs, Panel-Track Supplements, 180-day Supplements, Real-Time Supplements, and 30-Day Notices/135-Day Supplements. It does not cover PMA Modules or Modular Shells.
It also does not address the information needed for filing review, and FDA says it’s not meant to specify eSTAR’s user interface or detailed content. Its job is narrower: to establish the PMA electronic format and standards under section 745A(b)(3) of the FD&C Act.
Part of this will be binding
Most FDA guidance is nonbinding, and most of this one is, too.
But the draft is explicit that where it sets out standards, a timetable, or criteria for waivers and exemptions under section 745A(b), those provisions will have binding effect once final. The FDA signals which parts those are through mandatory words like must and required.
Section 745A(b)(3) gives FDA statutory authority to set these requirements through guidance, which is why the usual rule that guidance cannot create enforceable obligations does not apply to those provisions.
The practical consequence sits in section VI so read it carefully! Once the requirement takes effect, a Designated Application Type not submitted as an electronic submission “will not be considered received” unless an exemption applies.
The FDA anticipates technical screening instead of RTA review
This is the operational change we see as most likely to matter to a PMA team (and the consultants among us).
Because a properly prepared eSTAR should represent an administratively complete submission, the FDA says Original PMAs and Panel-Track Supplements (the two types currently subject to refuse-to-accept review) are not anticipated to go through RTA.
In its place, the FDA says it intends to run virus scanning and a technical screening. For Original and Panel-Track PMAs, the draft guidance notes that technical screening confirms that the content of the PMA Acceptance Checklist has been submitted.
Technical screening checks two things: that your eSTAR responses accurately describe the device (the guidance’s example is confirming there are in fact no tissue-contacting components if you indicated none), and that there is at least one relevant attachment for each applicable attachment-type question.
Here are the mechanics of that, as the draft lays them out:
Screening is anticipated to occur within 15 calendar days of the FDA receiving the PMA eSTAR.
The FDA intends to begin screening only where the appropriate user fee has been paid.
If the submission fails, the FDA notifies you by email, identifies what is incomplete, and places the submission on hold until you respond.
A response received within the 360-day timeframe is logged as an amendment. If no response arrives within 360 days of the deficiency notification, the FDA considers the submission withdrawn and closes it.
When you respond, the review clock restarts at day 0, and the FDA screens again within the first 15 days of the restarted clock.
Once the submission passes, the clock continues, the FDA notifies you electronically, and the submission proceeds to substantive review.
Original PMAs and Panel-Track Supplements that pass screening still go through filing review, which occurs within 45 calendar days after FDA receives the submission.
What the template asks for
Table 1 of the draft lays out the current PMA eSTAR structure, from submission type and device description through benefit-risk, labeling, the technical testing sections, and amendment responses.
A few details worth flagging:
The manufacturing section is labeled Quality Management System Regulation (QMSR) Information, covering the methods, facilities, and controls used for designing, manufacturing, packaging, labeling, storing, installing, and servicing the device.
Post-Market Study Plans refers to post-approval studies that may be required as a condition of approval, and FDA specifies it does not include 522 studies.
Market History asks for all countries where the device has been marketed and all countries where it has been withdrawn for any reason related to safety or effectiveness.
For additional information responses, FDA wants the actual changes placed in the relevant section of the eSTAR (updated labeling goes in the Labeling section), not only in the AI response section.
The FDA also notes that eSTAR is structured to closely follow SMART, the Submission Memo And Review Template reviewers use internally for certain PMA submission types.