Regulatory Deadline Board/2026-19181
Food and Drug Administration · Notice
Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs); Draft Guidance for Industry and Food and Drug Administration Staff; Availability
19 days left
In plain English
FDA published draft guidance on an electronic submission template for medical device PMA applications to CDRH and CBER.
Who it hits
PMA sponsors, eCopy and eSTAR vendors, and regulatory consultants who prepare Class III device filings.
- Agency
- Food and Drug Administration
- Document type
- Notice
- Published
- Sep 18, 2026
- Comments close
- Nov 17, 2026
- Status
- 19 days left
- Federal Register number
- 2026-19181
- Docket
- Docket No. FDA-2026-D-9429
More from Food and Drug Administration
Notice · 60 days left
Electronic Submission Template for Investigational Device Exemption (IDE) Applications; Draft Guidance for Sponsors and Food and Drug Administration Staff; Availability
Notice · 29 days left
Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management; Draft Guidance for Industry; Availability
Notice · 12 days left
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Tracking
Notice · 11 days left
Improving Patient Access to Deceased Donor Islet Cells and Cell Products; Request for Information
Notice · 5 days left
Establishment of a Quantitative Medicine Innovation Network: Scope, Feasibility, and Opportunities; Request for Information
Proposed Rule · Closed 13 days ago
Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments