FDA's New E-Template: Easier Med Device Paperwork Ahead?
Published Date: 9/18/2026
Notice
Summary
The FDA just dropped a draft guide to help medical device makers submit their big approval applications electronically. This new template aims to make submissions easier, faster, and more consistent for companies working with the FDA’s device and biologics centers. If you’re in the medical device game, check it out and send your feedback by November 17, 2026—no fees or changes yet, just a heads-up for smoother future filings!
Analyzed Economic Effects
5 provisions identified: 4 benefits, 0 costs, 1 mixed.
Moves Toward Mandatory Electronic Standards
The draft guidance is one step toward implementing section 745A(b) of the FD&C Act, which lets FDA set standards, a timetable, and criteria for waivers or exemptions for submissions made solely in electronic format. When finalized, the guidance will help implement those standards and timetables for certain PMAs.
Draft PMA Electronic Template Released
The FDA released a draft guidance called "Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs)" to help companies submit certain PMAs electronically. The draft is not final or for implementation now and is intended to improve submission consistency and speed in the review process.
Which PMA Types Are Covered
The draft guidance explicitly covers electronic submissions for Original PMAs, Panel-Track Supplements, 180-day Supplements, Real Time Supplements, and 30-Day Notices/135-Day Supplements. If you submit any of these PMA types to CDRH or CBER, this guidance is intended to introduce you to the current electronic submission resources.
Opportunity to Comment by November 17, 2026
FDA is accepting written or electronic comments on this draft guidance through November 17, 2026. If you are a PMA submitter or stakeholder and want FDA to consider your views before finalizing the guidance, submit comments to docket FDA-2026-D-9429 by that date.
No New Paperwork Burden Now
The guidance states it contains no new collection of information under the Paperwork Reduction Act and refers to already approved collections (for example, OMB control Nos. 0910-0231, 0910-0485, and 0910-0073). This means the draft does not add new paperwork requirements now.
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