FDA Proposes Class I for Device Accessories Seeks Public Input
Published Date: 8/17/2026
Proposed Rule
Summary
As required by the FDA Reauthorization Act of 2017 (FDARA), the Food and Drug Administration (FDA or Agency) has identified a list of accessories for which the Agency believes general controls alone are sufficient to provide reasonable assurance of safety and effectiveness, making them appropriate for class I classification. FDA is publishing this document proposing to classify these accessories into class I and distinct from other devices, as well as seeking public comment in accordance with procedures established by FDARA. This document does not represent FDA's final determination with respect to the proposed accessories listed in this document.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Listed Accessories Proposed as Class I
If you make or sell any of the accessories listed by FDA, the agency proposes to classify them as Class I devices distinct from their parent devices. The listed accessories include: a noninvasive blood pressure tubing (DXN), implantable pacemaker electrocardiogram cables (DXY and OSR), extracorporeal membrane oxygenation non‑electrical accessories (QJZ and QNR), auxiliary power supply for low‑energy defibrillators (MPD), urological catheter sterile plug (KNY), detachable suction sleeve for smoke evacuating monopolar pencil (GEI), and power charger accessories for battery‑powered surgical instruments (GAG and GDW). If finalized, each would be Class I and exempt from the premarket notification procedures in 21 CFR part 807, subject to applicable limitations of exemption.
Eligibility Limits for Distinct Class I Status
FDA says accessories that require design and development controls or are device‑specific are generally not eligible for distinct Class I classification. In particular, Class I design controls apply only if the device is automated with computer software or listed under 21 CFR 820.10(c)(2); device‑specific accessories based on unique dimensions/geometry are also generally ineligible.
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Key Dates
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