# 2026-19181: FDA's New E-Template: Easier Med Device Paperwork Ahead? 2026-19181, Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs); Draft Guidance for Industry and Food and Drug Administration Staff; Availability, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2026-09-18, effective Submit either electronic or written comments on the draft guidance by November 17, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.; PRIA reads it as touching household money (as of 2026-09-25). - Canonical: https://policyrisk.com/federal-register/2026-19181 - As of: 2026-09-25 - Plain-text twin of the page above; the HTML and this file carry the same facts. ## Facts - Document number: 2026-19181 - Title: Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs); Draft Guidance for Industry and Food and Drug Administration Staff; Availability - Type: Notice - Agencies: Health and Human Services Department; Food and Drug Administration - Citation: 91 FR 59138 - Published: 2026-09-18 - Effective: Submit either electronic or written comments on the draft guidance by November 17, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. - Comments close: 2026-11-17 - Significant: no - Touches household money: yes - Regulation identifier numbers: none - Last updated: 2026-09-25 ## In one line FDA's New E-Template: Easier Med Device Paperwork Ahead? ## 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! ## Abstract The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs)." FDA is issuing this draft guidance for submitters of certain PMAs to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER). It introduces those submitters to the current publicly available resources and associated content developed to support electronic submissions of certain PMAs and PMA supplements to FDA. This draft guidance, when finalized, is intended to represent one of several steps in meeting FDA's commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process. This draft guidance is not final nor is it for implementation at this time. ## Effects PRIA read - Draft PMA Electronic Template Released: benefit, medium. 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 t… - Which PMA Types Are Covered: benefit, low. 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… - Moves Toward Mandatory Electronic Standards: mixed, high. 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… - Opportunity to Comment by November 17, 2026: benefit, low. 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: benefit, low. 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. ## Related documents - [2026-16296](https://policyrisk.com/federal-register/2026-16296): Substances Generally Recognized as Safe, 2026-08-11 - [2026-14073](https://policyrisk.com/federal-register/2026-14073): Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign E…, 2026-07-13 - [2026-13047](https://policyrisk.com/federal-register/2026-13047): Establishment Registration and Product Listing for Tobacco Products, 2026-06-29 - [2025-04978](https://policyrisk.com/federal-register/2025-04978): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-03-25 - [2025-01840](https://policyrisk.com/federal-register/2025-01840): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-01-27 - [2026-20727](https://policyrisk.com/federal-register/2026-20727): Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorgani…, 2026-10-09 ## Sources - [2026-19181 on federalregister.gov](https://www.federalregister.gov/documents/2026/09/18/2026-19181/electronic-submission-template-for-medical-device-premarket-approval-applications-pmas-draft) - [2026-19181 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-09-18/pdf/2026-19181.pdf) ## Related - [Previous: 2026-19180, City of Aspen, Colorado; Notice of Application Accepted for Filing and Soliciti…](https://policyrisk.com/federal-register/2026-19180) - [Next: 2026-19183, Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting](https://policyrisk.com/federal-register/2026-19183) - [All Federal Register documents](https://policyrisk.com/federal-register) Source: PRIA, https://policyrisk.com/federal-register/2026-19181 (as of 2026-09-25).