FDA Proposes Easy Class for Device Accessories, Seeks Comments
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.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-16728, Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer
The Food and Drug Administration (FDA) is proposing to reclassify diagnostic endoscopic light source systems (product code OAY), which are postamendments class III devices, from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name "Cystoscopic system intended as an aid for detection of bladder cancer," along with special controls that FDA believes are necessary to provide a reasonable assurance of the safety and effectiveness of these devices.
2026-16715, Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
2026-16727, Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order reclassifying in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK), all postamendments class III (premarket approval) devices, into class II (special controls), subject to premarket notification. FDA is also establishing a new device classification regulation, along with the special controls that are necessary to provide a reasonable assurance of safety and effectiveness of this device type.
Previous / Next Documents
Previous: 2026-16728, Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer
The Food and Drug Administration (FDA) is proposing to reclassify diagnostic endoscopic light source systems (product code OAY), which are postamendments class III devices, from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name "Cystoscopic system intended as an aid for detection of bladder cancer," along with special controls that FDA believes are necessary to provide a reasonable assurance of the safety and effectiveness of these devices.
Next: 2026-16750, Establishment of Class E Airspace; DeKalb, IL
This action proposes to establish Class E airspace at Northwestern Memorial Healthcare Heliport, DeKalb, IL. The FAA is proposing this action to support new instrument procedures and instrument flight rule (IFR) operations.