Federal Register #FDA2025N6224

FDA Request for Comments: Proposed Classification of Medical Device Accessories as Class I

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, is seeking public comments on its proposal to classify certain medical device accessories as Class I, distinct from other devices. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - No specific OEMs or vendors are mentioned - Products/Accessories Proposed for Classification: - Noninvasive blood pressure measurement system accessories - Tubes connecting blood pressure cuffs to measurement systems - Electrocardiogram cables - Cables for transmitting signals between pacing devices and cardiac leads - Extracorporeal membrane oxygenation accessories - Non-electrical devices supporting oxygenation circuits (e.g., mounting brackets, priming equipment) - Auxiliary power supply for low-energy direct-current defibrillator - Battery charging accessories - Urological catheter plug - Sterile plugs for sealing catheter ends - Detachable suction sleeve - Single-use, sterile sleeves for smoke evacuation in surgery - Power charger accessory for battery-powered surgical instruments - Electrical charging accessories - Notable Requirements: - Accessories must not be for life-supporting or sustaining use - Must not present unreasonable risk - Subject to general regulatory controls for safety and effectiveness - FDA is requesting stakeholder feedback to inform final classification - No specific part numbers, models, or purchase quantities provided - FDA also proposes reclassifying diagnostic endoscopic light source systems to Class II for cystoscopic systems aiding bladder cancer detection - This is a request for information and comment, not a procurement for purchase

Description

The Food and Drug Administration (FDA) is proposing to classify certain medical device accessories into Class I distinct from other devices. This proposal is pursuant to section 513(f)(6)(D)(i) of the FD&C Act and seeks public comments on the proposed list of accessories suitable for Class I classification. The classification is based on the risks of the accessory when used as intended and the level of regulatory controls necessary to assure safety and effectiveness. Comments on the proposal must be submitted by October 16, 2026. The document does not represent FDA's final determination and invites feedback from the public.

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