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GUIDANCE DOCUMENT

Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements Guidance for Industry and Food and Drug Administration Staff June 2026

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2014-D-0967
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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.
 

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All written comments should be identified with this document's docket number: FDA-2014-D-0967.

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