All regulations
Nonrulemaking
FDA
Open for Comments
FDA-2025-P-5435
Request that the FDA take a regulatory action against certain manufacturers of recently introduced surgical stapling system products for making unsubstantiated claim(s) regarding clinical performance of the products.
Documents
3
Comments
4
Description
OPEN
Key Dates
Comment Period OpensOct 16, 2025
Documents
| Type | Title | Status |
|---|---|---|
Other |
Comment Statistics
Total Comments
4
Keywords
CDRH
Citizen Petition
take a regulatory action against certain
manufacturers of recently introduced
surgical stapling system products for making
unsubstantiated claim(s) regarding
clinical performance of the products
OPEN
Data from Regulations.gov