Federal Register #Docket No. FDA-2026-N-2959

FDA Classifies Medical Devices for Congestion Relief and Orthopedic Implant Selection as Class II with Special Controls

This summary covers the FDA's regulatory classification of certain medical devices: - Government Buyer: - Food and Drug Administration (FDA), Center for Devices and Radiological Health - OEMs and Vendors Mentioned: - Tivic Health Systems Inc. (OEM for ClearUP Sinus Relief device) - Products/Devices Classified: - Transcutaneous electrical nerve stimulator for relief of congestion - Electrically stimulates the skin over the paranasal sinuses to relieve congestion - Example: ClearUP Sinus Relief device - Manual surgical instrument for appropriate patient selection for orthopedic implant - Special Controls and Requirements: - Non-clinical performance testing - Software verification and validation - Biocompatibility testing - Human factors testing - Detailed labeling requirements - Purpose and Impact: - Devices classified as Class II with special controls to ensure safety and effectiveness - Intended to reduce regulatory burdens and enhance patient access to innovative devices - Not a procurement or award: - This is a regulatory classification action, not a solicitation for purchase or contract award

Description

The Food and Drug Administration (FDA) is classifying the transcutaneous electrical nerve stimulator for the relief of congestion as a class II medical device with special controls. This device electrically stimulates the skin overlying the paranasal sinuses to relieve congestion. The classification includes specific special controls such as non-clinical performance testing, software validation, biocompatibility, human factors testing, and detailed labeling requirements to ensure safety and effectiveness. This action aims to provide reasonable assurance of safety and effectiveness while enhancing patient access to innovative devices by reducing regulatory burdens.

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