FDA PMA eSTAR Draft Guidance: What Sponsors Need to Know

On September 18, 2026, FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) issued a draft guidance that would require electronic submission through eSTAR for specified Premarket Approval (PMA) applications and PMA supplements.

If FDA finalizes it as proposed, sponsors would get a transition period of at least one year before the requirement applies. Until then, eSTAR use is voluntary. Existing submission requirements, including any applicable eCopy requirements, still apply.

This article covers what FDA is proposing and how to prepare during the transition.

FDA PMA eSTAR Guidance at a Glance

The draft proposes electronic-only submission for five PMA application types, with a 15-day technical screen and a 360-day deficiency window.

What Is Changing for PMA Submissions?

Designated Application Types would move from an eCopy to an eSubmission built in eSTAR. Today, an eCopy is the electronic duplicate of what used to be the paper submission, formatted to FDA’s technical standards. FDA does not treat it as an electronic submission. An eSTAR works differently. FDA’s template walks the applicant through the content, and the structured answers and attachments together make up the submission.

FDA describes the guidance as one step in its commitment to develop templates that “improve submission consistency and enhance efficiency in the review process.”

Electronic submission would be required for Designated Application Types

Once the guidance is final, Designated Application Types would have to be submitted as electronic submissions starting on the implementation date, unless exempt. After that date, FDA would not consider a Designated Application Type received if it was not provided as an electronic submission, unless an exemption applies.

That applies only after finalization and only from the date FDA sets. This draft does not require eSTAR for any PMA submission today.

eSTAR structures how the submission is prepared

eSTAR is a guided template with integrated databases, targeted questions and links to relevant guidances. FDA separates two kinds of content.

• Structured data is what an applicant enters in fields, dropdowns and checkboxes.
• Unstructured data is what an applicant attaches, such as documents, PDFs, images and videos.

When every required section is filled in, the PDF displays “eSTAR Complete”. The template’s structure closely follows the Submission Memo And Review Template (SMART), an internal tool FDA reviewers use for certain PMA submissions (Draft §V). Its sections follow the content of a PMA, from device description and benefit-risk to labeling, performance testing, Quality Management System Regulation (QMSR) information and amendment responses. Sponsors already produce most of this content. What changes is where it goes and how it must line up.

Sponsors will need to adapt internal workflows

The draft does not prescribe how a sponsor runs its internal process. But the template pulls content from several functions at once.

• Regulatory affairs owns the submission and the structured fields.
• Quality and document control own the QMSR content and version control.
• Clinical and biostatistics own performance testing and clinical information.
• Engineering and technical writers own the device description and testing summaries.
• Project management owns the sequencing and handoffs.

Sponsors tend to underestimate how much work it takes to keep the attachments consistent with the structured fields.

Technical screening is a separate step from filing and substantive review

Under the draft, FDA would screen every eSTAR submission for technical completeness before substantive review begins. This is separate from filing and from substantive review. The technical screening section below explains what it checks and how the 360-day deficiency rule works.

Which PMA Submissions Are Covered?

The draft covers five Designated Application Types. They are described below:

Not every PMA supplement is named. The draft lists five types, and Special PMA Supplements and Manufacturing Site Change Supplements are not among them. FDA’s eCopy page puts both in a separate group, “all other PMA submission types,” where an eCopy is still required. FDA says it will update the guidance as other PMA submission types are implemented in eSTAR.

Which FDA centers are in scope?

Both CDRH and CBER. They do not use identical procedures, as the CDRH vs. CBER section explains below.

What is outside the scope?

PMA Modules and Modular Shells are excluded. FDA also intends to exempt the following once the guidance is final.

• Interactive review responses
• Certain amendments, such as appeals and supervisory review requests, substantive summary requests, changes in correspondent, legal entity or address, amendments after decision (for example, final labeling), and withdrawal requests
• Annual or periodic report and post-approval study reports

Some exempted items remain subject to any applicable eCopy requirements.

When Will PMA eSTAR Become Mandatory?

No implementation date exists. The draft says the date will be specified when the guidance is finalized. The proposed sequence:

Draft guidance (September 18, 2026)
↓
Public comment (closes November 17, 2026)
↓
FDA finalizes guidance
↓
Transition period: at least one year intended
↓
Implementation date
↓
Electronic submission required for Designated Application Types

The September 18, 2026 draft does not by itself require anyone to submit a PMA through eSTAR. FDA states that “currently, and during the transition period,” eSTAR may be used voluntarily.

Guidance is usually nonbinding, but this one is different. FDA says the final guidance will contain both binding and nonbinding provisions. The parts that set the standards, the time table and the criteria for waivers and exemptions under section 745A(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act would be binding . Until FDA finalizes it, nothing in the draft is binding.

How to Submit a PMA Using eSTAR Under the Draft Guidance

Prepare, submit, pass technical screening, then enter substantive review. This is a high-level view of the proposed workflow.

Step 1: Prepare the submission in eSTAR.

The applicant downloads the free eSTAR PDF from FDA’s eSTAR Program page. As of that page’s September 21, 2026 update, the current PMA templates are the non-in vitro diagnostic (nIVD) and in vitro diagnostic (IVD) eSTAR, both version 7.1. A new submission should use the current version. FDA says a submission is “grandfathered” to its eSTAR version once the applicant receives the acknowledgment letter.

After that, an answer to an additional information or technical screening request should update the original eSTAR instead of switching versions.

Step 2: Provide structured information and attachments.

The applicant should complete the applicable fields and attach supporting documents. As a best practice, the applicant should also check that cross-references and document versions match.

For amendment responses, FDA says the applicant should put the actual changes in the relevant eSTAR section, such as updated labeling in the Labeling section.

Step 3: Submit through the applicable FDA process.

The applicant should first confirm whether the submission goes to CDRH or CBER. The applicant should also confirm user-fee status, because FDA intends to begin technical screening only where the appropriate fee has been paid. As a best practice, the applicant should keep proof of submission.

Step 4: FDA conducts technical screening.

If the eSTAR doesn’t pass, FDA notifies the applicant by email and identifies the incomplete information. The applicant should monitor FDA email so the notification is not missed.

Step 5: Address deficiencies.

Under the draft, the applicant would need to respond with an updated eSTAR within 360 days of the deficiency notification, or FDA would consider the submission withdrawn and close it. The response adds the missing information to the applicable sections.

Step 6: The submission enters substantive review.

Once it passes screening, FDA notifies the applicant electronically and the submission proceeds to substantive review. Passing technical screening is not approval. Original PMAs and Panel-Track Supplements also undergo filing review, which FDA says occurs within 45 calendar days after receipt.

PMA eSTAR Technical Screening: The 15-Day Screen and the 360-Day Deficiency Rule

FDA anticipates technical screening within 15 calendar days of receiving a PMA eSTAR. If a submission does not pass, the applicant would have 360 days to respond before FDA considers it withdrawn. Both are proposals in the draft, not current requirements .

What technical screening checks

FDA intends to use virus scanning and technical screening for eSTAR submissions. It intends to begin technical screening only where the appropriate user fee has been paid. The 15-day figure is “anticipated” in the draft. It is a target, not a guarantee, and it says nothing about how long substantive review will take.

The screen is a completeness and consistency check. It confirms that eSTAR responses accurately describe the device, for example that no tissue-contacting components exist when the applicant said none do. It also confirms that each applicable attachment question has at least one relevant attachment. It is not a review of scientific, clinical, manufacturing or regulatory merit. That comes later, in substantive review, and passing screening does not mean approval.

Why the RTA process does not apply to eSTAR submissions

Original PMAs and Panel-Track Supplements currently go through the Refuse to Accept (RTA) process, described in FDA’s Acceptance and Filing Reviews for PMAs guidance (December 2019). This is FDA’s early check that an application is administratively complete before substantive review begins. If an application fails, FDA can refuse to accept it, and the review does not start.

Under the draft, eSTAR submissions of these two types would not go through the RTA process. FDA’s reasoning is that a properly prepared eSTAR should already be administratively complete. These submissions go through technical screening, and if they pass, a filing review follows.

The 360-day deficiency rule

Under the draft, a submission that fails technical screening stays on hold. The applicant then has 360 days to respond before FDA treats it as withdrawn.

• FDA notifies the applicant by email and identifies the incomplete information.
• The submission is placed and remains on hold.
• A response received within 360 days, meaning an updated eSTAR with additional information, is logged as an amendment.
• If no response arrives within 360 days of the deficiency notification, FDA will consider the PMA or supplement withdrawn and close it in the system.
• When new information arrives, the review clock restarts at day 0, and FDA screens again within the first 15 days.
• Once a submission passes, the clock continues and it proceeds to substantive review.

The draft does not describe an extension for the 360 days. FDA’s eSTAR page describes a 180-day hold in the context of the 510(k) and De Novo guidances, so sponsors should not apply that figure to PMAs.

CDRH vs. CBER Submission Processes

CDRH submissions go through FDA’s electronic portal. CBER submissions go through the Electronic Submissions Gateway (ESG). The draft states that a CDRH submission must use FDA’s electronic portal, and that CBER submissions follow FDA’s CBER submission instructions.

CDRH submissions use the CDRH Portal. Some submissions cannot go through the portal for known technical reasons. Those are mailed to the CDRH Document Control Center.

CBER submissions follow Regulatory Submissions in Electronic and Paper Format for CBER-Regulated Products. That is the title on FDA’s current page. The draft cites it as “Regulatory Submissions in Electronic Format for CBER-Regulated Products.”

Contacts for preparation questions are OPEQSubmissionSupport@fda.hhs.gov for CDRH and ESUBPREP@fda.hhs.gov for CBER.

The responsible center should be confirmed first, because it determines the route.

What Should PMA Sponsors Do Now?

Sponsors can use the transition to test their process, but should not rewrite SOPs around a draft.

1. Map the PMA Pipeline

Sponsors should list upcoming Original PMAs, Panel-Track, 180-day, Real-Time and 30-Day Notice/135-Day submissions. They should flag which fall in the proposed scope and which fall under the draft’s exemptions, such as periodic reports.

2. Review the Current Submission Process

Sponsors should look at where information is collected, who owns each section, how supporting documents are generated and approved, how versions are controlled and where bottlenecks form.

3. Familiarize the Team With eSTAR

Regulatory, quality, clinical, engineering, manufacturing, biostatistics, medical writing and document control should all see the template. The draft does not mention any training requirement.

4. Build an Internal eSTAR Checklist

The checklist should map structured fields, attachments, owners, reviewers, approval points, versions and milestones.

5. Update Deficiency-Response Procedures

Procedures should cover ownership, tracking, escalation, management review, document control and amendment tracking, reflecting the proposed 360-day provision.

6. Test the Workflow During the Transition

FDA states that eSTARs may be used voluntarily for PMAs and PMA supplements currently and during the transition. A lower-stakes submission can be a practical way to find gaps.

7. Monitor the Final Guidance

Sponsors can comment on the draft until November 17, 2026 at docket FDA-2026-D-9429 on regulations.gov.

Conclusion

The PMA eSTAR requirement is not in effect, but the draft shows where FDA is heading. Sponsors can use the transition period to review current PMA submission workflows, get teams familiar with eSTAR, map upcoming submissions, set up deficiency-management procedures, tighten document and version control, and watch for the final guidance and implementation date.

If your team is preparing for upcoming PMA submissions or assessing the impact of FDA’s proposed eSTAR requirements, connect with info@artixio.com for practical support with submission planning, document readiness, eSTAR preparation and FDA regulatory strategy.

FAQs

Q1. Is PMA eSTAR mandatory now?
No. The guidance is a draft marked “Not for Implementation.” Today, FDA’s eCopy page lists an eCopy as required for these PMA types, and eSTAR is a voluntary option. A requirement would apply only after FDA finalizes the guidance and the implementation date passes.

Q2. When will PMA eSTAR become mandatory?
No implementation date exists. FDA will specify it in the final guidance and intends at least one year between final guidance and implementation.

Q3. Which PMA submissions are covered by eSTAR?
The draft covers five Designated Application Types. They are Original PMAs, Panel-Track Supplements, 180-Day Supplements, Real-Time Supplements, and 30-Day Notices/135-Day Supplements. PMA Modules and Modular Shells are excluded, and FDA lists several exemptions.

Q4. How do you submit a PMA using eSTAR?
Today, eSTAR use is voluntary, and applicants should follow FDA’s current instructions. At a high level, the applicant prepares the submission in eSTAR, completes the structured fields, adds attachments, and submits through the CDRH Portal or, for CBER, the Electronic Submissions Gateway. FDA then conducts technical screening, and the submission moves to substantive review once it passes.

Q5. What happens if a sponsor does not respond within 360 days?
Under the draft, FDA would consider the PMA or supplement withdrawn and close it. The 360 days run from the technical screening deficiency notification, and a timely response is logged as an amendment.