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Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs); Draft Guidance for Industry and Food and Drug Administration Staff; Availability
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Summary (from the Federal Register 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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs)." FDA is issuing this draft guidance for submitters of certain PMAs to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER).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 This draft guidance, when finalized, is intended to represent one of several steps in meeting FDA's commitment to the development of electronic submission templates to serve as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 This draft guidance is not final nor is it for implementation at this time.
- Document type
- Notice
- Federal Register document number
- 2026-19181
- Published
- Sep 18, 2026
- Action
- Notice of availability.
- Docket
- FDA-2026-D-9429
- Comments posted on Regulations.gov (at last check)
- 0
- DATES section (from the document)
- Submit either electronic or written comments on the draft guidance by November 17, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
- Topics (auto-tagged)
- Vaccines / biologics Medical devices
Source: Federal Register API, document 2026-19181. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.