FDA issued draft guidance on September 18 introducing an electronic submission template for premarket approval applications. It covers original PMAs, panel-track supplements, 180-day supplements, real-time supplements and 30-day notices, the ones that convert to 135-day supplements. Comments close November 17 under docket FDA-2026-D-9429.
The template works the way eSTAR does for 510(k)s: a guided form that will not let a submitter leave a required element blank before the file goes to CDRH or CBER. FDA is acting under section 745A(b) of the Federal Food, Drug, and Cosmetic Act, added by the 2017 reauthorization, the same authority behind mandatory electronic formats for 510(k)s.
The 510(k) version cut acceptance-review holds because the form catches a missing section before a reviewer does. A PMA runs far longer and carries manufacturing, clinical and labeling modules, so there is more for the form to catch. First-time filers should expect the template to add weeks to assembly and take them off the reviewer's back later.