Federal Register #2026-11303

FDA Guidance Exempts Additional Unclassified Medical Devices from Premarket Notification

This opportunity concerns the FDA's announcement of new guidance regarding medical device regulation: - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Purpose: - Issuance of guidance to exempt certain unclassified medical devices from premarket notification (510(k)) requirements - Key Details: - The guidance adds five new device types to the exemption list: - LDK: Device, sensing, optical contour - MVV: Device, acupressure - MQZ: Prosthesis, nail - MIG: Strip, test isoniazid - LXQ: Cup, eye - No specific OEMs or vendors are named - No procurement of products or services is requested - Notable Requirements: - The guidance is implemented without prior public comment but remains open for feedback - Supersedes previous guidance by expanding the list of exempted devices - No contract, purchase, or solicitation for goods or services is involved in this announcement

Description

The Food and Drug Administration (FDA) announces the availability of guidance titled "Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements." This guidance outlines FDA's intent to exempt certain unclassified medical devices from premarket notification requirements, believing these devices meet exemption standards. The guidance is implemented without prior comment but remains open for comments according to FDA's good guidance practices. It updates and supersedes the June 2019 guidance by including five additional product codes recommended for classification into class I or II.

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