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We have another eSTAR-related draft guidance for the device and medtech professionals among us. Today, we have something unique: an additional set of perspectives on a topic we plan to cover in our next monthly deep-dive. (The voiceover in this one is synthetic.)
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Now to the draft guidance: Electronic Submission Template for Premarket Approval Applications (PMAs). It would extend eSTAR (which has been mandatory for 510(k)s since October 2023 and for De Novo requests since October 2025) to original PMAs, several PMA supplement types, and 30-Day Notices.
Jesse Hart, a compliance consultant with 27 years of experience in regulated industries and a contributing author of our deep dives, expects most PMA teams to be working within this template within about two years. He read the draft the way he would if a client had just hired him to get them ready.
“The direction is clear. If FDA finalizes this as proposed, you will submit this way. What teams can work on now is the operational question: documents, people, and calendar.”
That kind of problem is where he’s spent most of his career: large remediation programs, electronic records transitions, and document systems that had to hold up under an investigator. Below is his walkthrough of what the draft says, what changes day to day, what he thinks it means, and what he’d have a team doing before the end of the year. Quotes are lightly edited for clarity.
You can get Jesse’s slide deck here:
Important to note, as always, when we dissect a draft guidance: it’s a draft! It’s not for implementation. The comment period runs 60 days from the September 18 Federal Register notice, through November 17, 2026, under docket FDA-2026-D-9429.
What the draft covers
The FDA calls the submissions in scope the “Designated Application Types.” That includes:
Original PMAs
Panel-Track Supplements
180-day Supplements
Real-Time Supplements
30-Day Notices and 135-Day Supplements
PMA Modules and Modular Shells are not included.
Once the guidance is final, the FDA says intends to provide a transition period of at least one year from the final guidance’s issuance before requiring eSTAR. After that, a submission for a Designated Application Type that doesn’t arrive as an electronic submission will not be considered received unless an exemption applies. “Not rejected,” Jesse notes. “Not received.”
Two things set this draft apart from ordinary guidance:
The standards, the timetable, and the criteria for waivers and exemptions are issued under section 745A(b)(3) of the FD&C Act, so they’ll be binding when final, outside the usual limits of FDA’s good guidance practices.
The FDA says that, at this time, it has not identified any circumstances appropriate for a waiver and does not intend to grant waiver requests.
“So the question for a firm is not whether. It’s when and how ready you are when it arrives.”
From refuse-to-accept to a technical screen
Original PMAs and Panel-Track Supplements go through refuse-to-accept (RTA) review today. Under the draft, they aren’t expected to. The FDA instead intends to run a technical screening process on PMA eSTARs, anticipated within 15 calendar days of receipt.
The draft describes that screen as checking two things: whether the eSTAR responses accurately describe the device, and whether every applicable attachment question has at least one relevant file attached. “Nobody is judging whether your biocompatibility rationale is persuasive at this stage,” Jesse notes. “They’re checking that the box you ticked has a document behind it.”
The rest of the mechanics here, per the draft:
The FDA intends to begin technical screening only once the user fee has been paid. “If finance pays a week after regulatory uploads, you’ve spent a week of calendar before the FDA has looked at anything.”
If the screen fails, the FDA notifies you by email, identifies the incomplete information, and places the submission on hold.
If the FDA doesn’t receive a response within 360 days of the deficiency notification, it considers the submission withdrawn and closes it.
When you do respond, the review clock restarts at day 0, and the FDA screens again within the first 15 days.
Original PMAs and Panel-Track Supplements that pass the screen then go through filing review, within 45 calendar days of the FDA receiving the submission.
The 510(k) precedent
This may be more manageable than it sounds because the 510(k) version of a closely analogous mechanism has been running since eSTAR became mandatory for 510(k)s in October 2023. It has the same technical screen and the same email hold. The difference is the window: a 510(k) is considered withdrawn if a replacement eSTAR isn’t received within 180 days, compared with 360 days in the PMA draft.
Jesse has supported several device submissions from the documentation side, including 510(k)s at a large ophthalmic manufacturer, where validation records and software documentation he produced went into the package for software as a medical device, including surgical planning calculators.
Earlier this year, he rebuilt the design history file, design controls, and ISO 14971 risk file for a Class II device already cleared under a 510(k).
“When I read Table 1, I’m reading a list of documents I’ve written, and the question this guidance asks is whether those documents are organized to be attached or organized to be rewritten.”
If there are people in your organization who filed a 510(k) in the last three years, they likely already know how the screen behaves. On a readiness project, finding them is the first thing he does.
The exemptions are narrower than people assume
“The exemption list is worth reading closely, because people will assume it’s broader than it is,” Jesse said. Upon finalization, FDA intends to exempt the following from the PMA electronic submission requirements:
Interactive review responses
Certain amendments: appeals and requests for supervisory review, substantive summary requests, changes in correspondent, legal entity, or applicant address, and amendments after decision, such as final labeling amendments
Withdrawal requests
Reports, including but not limited to annual and periodic reports under 21 CFR 814.84(b) and post-approval study reports
Exempt doesn’t mean gone. The amendments, withdrawal requests, and reports remain subject to any applicable eCopy requirements, and when a reviewer uses interactive review by phone or email, the draft says the applicant should reply to the reviewer by email. As Jesse put it, “They just travel a different road.”
Table 1 and the practical limits
Jesse calls Table 1 the backbone of the guidance. It lays out the current PMA eSTAR in 22 sections, starting with Submission Type. The starred technical sections cover reprocessing, sterility, shelf life, biocompatibility, software and cybersecurity, EMC and electrical, mechanical, wireless, and thermal safety, and performance testing.
The FDA says the information in those sections is intended to fulfill 21 CFR 814.20(b)(3)(v) and (b)(6)(i), with Performance Testing also covering (b)(6)(ii).
Then there are the technical limits, which, in Jesse’s words, “nobody reads until they hurt.” They come from FDA’s eSTAR program page, not the draft itself:
For submissions through the CDRH Portal, attachments are capped at 1 GB and the entire eSTAR at 4 GB.
CBER submissions through FDA’s Electronic Submissions Gateway have a 100 GB submission limit.
Across eSTAR, attachment names are capped at 124 characters.
ZIP files are automatically rejected.
Concurrent co-authoring of the dynamic PDF is not supported. Only one person should edit it at a time.
“For a 510(k), those were an inconvenience. For a PMA with clinical data, they’re a constraint you design around.”
What’s going on underneath
Jesse’s read on the draft comes down to four points.
First, the applicant’s submission structure moves closer to FDA’s review structure. The draft says eSTAR closely follows the content of SMART, an internal review tool FDA reviewers use for certain PMA submission types. Jesse’s operational read is that teams will benefit from organizing submission content around that structure earlier rather than translating into it at the end.
Second, the way submissions fail changes. Jesse sees the technical screen as a completeness check you can’t argue with. That makes it faster and far less forgiving, because a single missing attachment stops a 5,000-page submission the same way it stops a 50-page one. He once ran a Part 11 remediation across more than 40 systems at a large pharma site, and he thinks its lesson applies directly here: “Programs don’t fail on the hard technical questions. They fail on the item nobody owned.”
Third, the day-0 restart is a schedule risk to model, not one to hope around. Put it in the plan as a line item with a probability and a cost!
Fourth, no waivers mean every hour you might have spent drafting an exception request goes into readiness instead. And readiness here, he says, is document control and program management. “The regulatory content is the same content you already know how to write.”
What he’d have a team doing now
A few of Jesse’s recommendations for starting to operationalize this:
Run a voluntary eSTAR on a real submission during the transition. Jesse would pick a 180-day or Real-Time Supplement over an original. Make it a real project with a named owner, a frozen attachment list, a date, and a self-run screen before anyone touches the portal, where someone who didn’t assemble the package opens every applicable question and confirms there’s a file behind it. “Treat the result as a finding, not a learning experience.”
Map your current PMA outline against all 22 Table 1 sections, and write down every place a document has to be split, merged, or written fresh to fit. “That map is your readiness gap, and it’s usually longer than people expect, especially in the starred technical sections.”
Build an internal version of FDA’s technical screen: verify that each eSTAR response accurately describes the device and that every applicable attachment-type question has at least one relevant file attached.
Put the user fee into the project plan as a gate that sits before the upload date, not after. On the projects Jesse has run, the single most common cause of a lost week was something sitting in a queue in a different department, and fee payment is exactly that kind of item.
Reorganize your design history file index to Table 1 headings now, while nothing is due. His DHF rebuild earlier this year covered the index, traceability matrix, design review record, and risk file, and his takeaway is that a file organized to Table 1 “gets assembled into a submission. A file organized any other way gets rebuilt into one, and rebuilding is where the missing attachment comes from.”
Put the eSTAR limits into your document control procedure as requirements: the size caps, a naming convention, no zip archives, and one editor at a time on the template. “A dynamic PDF that two people have open is how you lose a day of work with no error message.”
Train the people who will touch the template, and keep the record. Training is the first thing an investigator asks for, Jesse noted, and under the QMSR, personnel competence and training are addressed through 21 CFR 820.10(a)’s incorporation of ISO 13485:2016 Clause 6.2; former §820.25 no longer applies.
Comment on the docket before the window closes on November 17. The provisions that would become binding when the guidance is finalized are still open to comment, and Jesse thinks the 360-day hold and the no-waiver position deserve a view from industry. “If you have a view, this is the moment it counts.”
References and more
Jesse points to four sources:
The draft guidance itself. Read the whole thing rather than a summary, he says, because Table 1 and the footnotes carry most of the operational detail.
Providing Regulatory Submissions for Medical Devices in Electronic Format: Submissions Under Section 745A(b) of the FD&C Act, the statutory framework this draft sits inside.
Acceptance and Filing Reviews for Premarket Approval Applications (PMAs), which describes the current acceptance/RTA and filing processes. Under the draft, eSTAR originals and Panel-Track Supplements would no longer be expected to undergo the RTA acceptance process, while the 45-day filing review would remain.
The FDA’s eSTAR program page, where the current template versions, portal requirements, and size limits live. That page changes more often than the guidance does, so check it before every submission rather than once.
Read the full draft guidance here.
Jesse Hart, MS, PMP, founded Hart Compliance Services in 2014 and launched its Hart AI Governance practice in 2025. Over 27 years, he has helped pharmaceutical, biotech, medical device, and regulated software companies build compliance programs, from 21 CFR Part 11 work beginning in 1999 to consent decree remediations, QMS builds, and, earlier this year, an FDA Form 483 response and quality system rebuild for a Class II device manufacturer.
Learn more at Hart AI Governance or connect with him on LinkedIn.
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