The supplement got eSTAR. The PMA did not.
FDA opened eSTAR to PMA 30-Day Notice supplements and IDE filings in September 2025, three years after the same template became mandatory for 510(k)s. An original PMA application — the filing that opens the file a supplement later amends — still has no eSTAR option at all, voluntary or otherwise.
By Connor Griggs — Regulatory & Quality Strategist
eSTAR reached a 510(k) in October 2023 and a De Novo request two years later, on October 1, 2025. Both are now mandatory: file the older way and FDA does not accept the submission at all. A PMA sponsor reading that timeline could reasonably assume the same clock is running toward premarket approval. It is not — and what actually arrived for PMA, the same month the De Novo mandate took effect, was something narrower.
What September 2025 actually turned on
FDA’s CDRH Portal opened voluntary eSTAR submission for two things in September 2025: original and supplement Investigational Device Exemption (IDE) filings, and PMA 30-Day Notice supplements — the fastest of the PMA change tracks under 21 CFR 814.39, for a manufacturing modification a sponsor can implement after a short FDA review window. Neither is the document that opens a PMA file. An IDE precedes one; a 30-Day Notice amends one already approved.
The original application still has no template
An original PMA — the application a sponsor files to win approval in the first place — has no eSTAR template at all, mandatory or voluntary, as of this post’s date. FDA’s own eSTAR program page lists what the template currently covers: 510(k), De Novo, Q-Submissions (still in draft guidance as of May 2025), and the narrow PMA and IDE categories above. A full PMA is filed and reviewed exactly as it was before eSTAR existed for any pathway, and FDA has not published a date, or a stated intention, to change that.
The template reached the amendment three years before it reached the application the amendment amends.
The practice
A company running both 510(k) and PMA programs is not living under one eSTAR regime; it is living under three, on three different clocks, only two of which have actually started. Filing a 510(k) or De Novo on paper today is not a choice — FDA will not accept it. Filing a PMA 30-Day Notice supplement through eSTAR is a choice a sponsor can make now, for speed. Filing the PMA application itself electronically, through the same template, is not yet a choice FDA has built — worth confirming against FDA’s own program page before a submissions team assumes eSTAR readiness covers every filing type on its calendar. This is regulatory intelligence and method, never regulatory advice about how a specific submission should be prepared or filed.
Primary sources
- FDA — eSTAR Program
- FDA — Send and Track Medical Device Premarket Submissions Online: CDRH Portal
- Federal Register — Electronic Submission Template for Medical Device De Novo Requests; Guidance for Industry and Food and Drug Administration Staff; Availability (Aug. 23, 2024)
- Federal Register — Electronic Submission Template for Medical Device Q-Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability (May 29, 2025)
- eCFR — 21 CFR 814.39, PMA supplements
Regulatory intelligence, not regulatory advice. This post describes method and published FDA records as of its date; decisions about a specific device belong with your regulatory professional.