Requests that the FDA issue an administrative order under 21 CFR Part 860 to reclassify Surgical Mesh for Stress Urinary Incontinence (Product Code: OTN / PAH) regulated under 21 CFR 878.3300 from Class II (Special Controls) to Class Ill (Premarket Approval) | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-11815

Requests that the FDA issue an administrative order under 21 CFR Part 860 to reclassify Surgical Mesh for Stress Urinary Incontinence (Product Code: OTN / PAH) regulated under 21 CFR 878.3300 from Class II (Special Controls) to Class Ill (Premarket Approval)

Documents

Comments

Description

Open

Key Dates

Comment Period OpensOct 5, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Citizen Petition from Clara Sands	Oct 5, 2026	--

Keywords

CDRH

Citizen Petition

Requests that the FDA issue an administrative

order under 21 CFR Part 860 to reclassify

Surgical Mesh for Stress Urinary Incontinence

(Product Code: OTN / PAH) regulated under

21 CFR 878.3300 from Class II (Special Controls)

to Class Ill (Premarket Approval)

Data from Regulations.gov