Search across the website

Find training courses, blog posts, guidelines, knowledge base articles and more.

to navigate esc to close to open

SOPP 8795: Posting and Announcement of Premarket Approval Application and Humanitarian Device Exemption Approvals and Denials

Version 2026-09-08

Download version
Publication
-
Effective Date
-
Filename
download
Checksum
2853723d1e3e41056731ae3ccfc7a9110032c932e91ad00cd5da62b31a88b3df

Change Summary

Imported from U.S. Food and Drug Administration source page.

Version Change Summary

1) Rationale for the change

Not specified for this version.

2) To whom it applies

Not specified for this version.

4) The current change description

Not specified for this version.

Newsletter Sign-up

Get Guideline Updates in Your Inbox

Subscribe for major GMP/GDP guideline changes, new publications and timeline updates.

We care about your data. Read our privacy policy .