Medical Devices; Exemptions from Premarket Notification: Certain Class II Devices; Request for Comments | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2026-N-4268

Medical Devices; Exemptions from Premarket Notification: Certain Class II Devices; Request for Comments

Documents

Comments

Description

Open

Comment Period OpensMay 1, 2026

Comment Period ClosesJul 1, 2026

Type	Title	Posted	Comments	Status
Supporting Material	Procedures for Class II Device Exemptions from Premarket Notification Guidance for Industry and CDRH Staff	May 11, 2026	--

Total Comments

CDRH

FRDTS # 2026-161

Medical Devices

Exemptions from Premarket Notification:

Certain Class II Devices

Request for Comments

Open