FDA Drafts an eSTAR Template for Device PMAs

FDA published a draft guidance on 18 September 2026 that would give medical device sponsors a standardized, eSTAR-based electronic template for Premarket Approval (PMA) applications — the class III pathway that guided electronic submission has not yet reached. The notice, issued jointly by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), calls the template “one of several steps” toward a fuller build-out of standardized submission tools, the same language FDA used before eSTAR became mandatory for most 510(k)s and, a year ago, for De Novo requests.

What eSTAR is, and where it hasn't reached yet

eSTAR — the electronic Submission Template And Resource — is FDA's interactive PDF tool for building a device submission: it walks a sponsor through the required sections, checks for missing content as they go, and produces a file structured the way CDRH reviewers expect to see it. FDA phased it in gradually. Most 510(k) submissions have used eSTAR for several years, and as of October 2025 the agency extended mandatory use to De Novo classification requests, the pathway for novel low- to moderate-risk devices. PMA — the pathway for the highest-risk, class III devices, and the most document-intensive submission type FDA reviews — has remained the holdout, with sponsors free to file on paper or in whatever electronic format they chose.

What the draft guidance actually does

The document itself is modest: it introduces PMA submitters to the public resources and content FDA has built to support eSTAR-based filing of certain PMAs and PMA supplements, and it does so as a draft, non-binding recommendation rather than a rule. Its statutory footing is Section 745A(b) of the Federal Food, Drug, and Cosmetic Act, as amended by Section 207 of the FDA Reauthorization Act of 2017 (FDARA) — the same provision that lets FDA set electronic submission formats, phase-in timetables, and exemption criteria for device filings generally. Because CBER shares jurisdiction over some PMA-regulated products, the guidance is issued jointly with CDRH, and FDA has not attached a specific finalization date or a mandatory-use deadline; both would come only after the agency reviews the comments it receives during the 60-day window.

Why the pattern matters more than the document

A draft guidance that merely introduces a voluntary template is easy to file away as low priority. The 510(k) and De Novo history argues against that: both pathways got a similar voluntary-introduction guidance well before FDA made eSTAR use mandatory, and neither transition left much runway once the mandatory date was set. FDA is negotiating device review timelines on a parallel track, too — the draft MDUFA VI recommendations FDA published in July would tighten the 510(k) review clock to 112 days by FY 2032 while holding PMA review time flat, and a standardized, checklist-driven PMA template is a plausible tool for hitting that kind of goal without adding reviewer headcount. Sponsors with a PMA or panel-track supplement in the pipeline for 2027 or later have a real interest in the comment period: it is the last point in the process where the template's structure, not just its existence, is still negotiable.

Frequently asked questions

What did FDA publish on 18 September 2026?

A draft guidance, "Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs)," issued jointly by CDRH and CBER. The notice ran in the Federal Register at 91 FR 59138, Docket No. FDA-2026-D-9429.

Which submission types does the template cover?

Original PMAs, Panel-Track Supplements, 180-Day Supplements, Real-Time Supplements, and 30-Day Notices/135-Day Supplements.

Is eSTAR now mandatory for PMAs?

No. FDA has not announced a mandatory-use date for PMAs. eSTAR is already mandatory for most 510(k) submissions and, since October 2025, for De Novo classification requests.

How do I comment, and by when?

Submit comments to Docket FDA-2026-D-9429 through Regulations.gov within 60 days of the 18 September publication date — by 17 November 2026.