Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements: Guidance for Industry and Food and Drug Administration Staff

Issue Date: June 5, 2026
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k)
Status: Final

Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements: Guidance for Industry and Food and Drug Administration Staff

This guidance describes the Food and Drug Administration’s (FDA’s) intent to exempt certain unclassified medical devices from premarket notification requirements. At this time, FDA believes the devices being added to this guidance meet the standards for exemption from premarket notification requirements. Until such exemption occurs, or until FDA becomes aware of new information affecting its current understanding, FDA does not intend to enforce compliance with 510(k) requirements for these devices. Due to this enforcement policy, FDA does not expect manufacturers to submit 510(k)s for these devices during this time period.

Download the Guidance Document