2026-16729: Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments

Federal Register, Volume 91 Issue 157 (Monday, August 17, 2026) [Federal Register Volume 91, Number 157 (Monday, August 17, 2026)] [Proposed Rules] [Pages 53205-53209] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2026-16729] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 870, 876, and 878 [Docket No. FDA-2025-N-6224] Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments

Agency

Food and Drug Administration, HHS.

Action

Notification; request for comments. -----------------------------------------------------------------------

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. [[Page 53206]]

Dates

Either electronic or written comments on the notification must be submitted by October 16, 2026.

Addresses

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of October 16, 2026. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. Electronic Submissions Submit electronic comments in the following way: Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2025-N-6224 for ``Medical Devices; Classification of Accessories Distinct from Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

For Further Information Contact

Ian Ostermiller, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5454, Silver Spring, MD 20993-0002, 301- 796-5678.

Supplementary Information

I. Background

The Federal Food, Drug, and Cosmetic Act (FD&C Act) sets forth a process to classify certain medical devices, i.e., accessories, separate from the parent device or system of devices with which the accessory is intended to be used. FDA refers to this process as distinct classification, and it originates from section 707 of FDARA, which was signed into law on August 18, 2017 (131 Stat. 1060-62, Pub.

II. Legal Authority

The accessories subject to this proposal are devices regulated under the FD&C Act. Specifically, section 201(h) of the FD&C Act defines a ``device'' to include, among other articles, an ``accessory'' (see 21 U.S.C. 321(h)). An accessory is a kind of device, and all articles that meet the definition of ``device'' are regulated under the FD&C Act. FDA has described our current thinking on which devices FDA would generally consider to be accessories in the guidance document, ``Medical Device Accessories--Describing Accessories and Classification Pathways''(``Accessories Guidance'').\2\ That guidance, based on sections 201(h) and 513(f)(6) of the FD&C Act, defines an accessory as a ``finished device that is intended to support, supplement, and/or augment the performance of one or more parent devices.'' --------------------------------------------------------------------------- \2\ Available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM429672. --------------------------------------------------------------------------- FDA regulates devices according to classes that reflect the regulatory controls necessary to provide reasonable assurance of their safety and effectiveness. Section 513 of the FD&C Act defines three classes of devices, which are class I (general controls), class II (special controls), and class III (premarket approval). Because accessories may have marketing [[Page 53207]] authorization as part of a submission for another device with which they are intended to be used, often called the parent device or system of devices, an accessory may be subject to more than general controls on account of the parent device or system of devices. However, for some such accessories, general controls alone may suffice to provide reasonable assurance of safety and effectiveness when the accessory is considered distinct from the parent device or system of devices. General controls, under section 513(h)(1) of the FD&C Act, are the controls authorized by or under sections 501, 502, 510, 516, 518, 519, and 520 of the FD&C Act (21 U.S.C. 351, 352, 360, 360f, 360h, 360i, and 360j). These controls include, but are not limited to, provisions related to adulteration and misbranding, registration and listing, records and reports on devices, and good manufacturing practices. The provisions for good manufacturing practices under 21 CFR part 820, the Quality Management System Regulation, include requirements for design and development controls for the manufacture of certain devices. However, requirements for design and development controls generally do not apply to class I devices except those identified in Sec. 820.10(c)(2) (21 CFR 820.10(c)(2)) and those automated with computer software. FDA is publishing this document pursuant to the legal authorities discussed in this notification and providing the public with the opportunity to comment on the proposals. Once the comment period ends, FDA will consider the comments and publish in the Federal Register a final action distinctly classifying suitable accessories into class I, if any.

III. Factors for Consideration

The classification of each accessory will be based on the risks of the accessory when used as intended and the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness of the accessory, notwithstanding the classification of any other device with which such accessory is intended to be used (see section 513(f)(6)(A) of the FD&C Act). In general, FDA considers an accessory to be eligible for classification into class I distinct from another device if the accessory: (1) is not for use in supporting or sustaining human life, or of substantial importance in preventing impairment to human health (see 21 CFR 860.3, defining ``life-supporting or life-sustaining device,'' among other terms); (2) does not present a potential unreasonable risk of illness or injury; and (3) general controls alone would be sufficient to provide a reasonable assurance of safety and effectiveness of the accessory. Note that by regulation, design and development controls apply to class I devices only if the devices are automated with computer software or are listed under Sec. 820.10(c)(2). Thus, if an accessory is not automated with computer software but would require design controls to provide reasonable assurance of safety and effectiveness, FDA does not consider it eligible for distinct classification through this process. Similarly, ``device-specific accessories'' are accessories designed for use with a specific parent device and/or system of devices, based upon unique dimensions, geometry, and/or deployment. In these cases, design specifications are critical to the proper use of the accessory in supporting, supplementing, and/or augmenting the performance of the parent device and/or the specific system. For such device-specific accessories, design and development controls are an important element of ensuring appropriate compatibility between the accessory and parent and/or system, and as such, device-specific accessories are not generally eligible for distinct classification through this process. In the Federal Register of August 17, 2018, FDA proposed this rationale for device-specific orthopedic instruments (83 FR 41023, 41025-26), which we then adopted in the Federal Register of April 12, 2019 (84 FR 14865, 14869). The same principle and definition apply to this proposal. You may wish to propose additional accessories as suitable for distinct classification into class I using the factors described above where the accessories are otherwise eligible for classification under section 513(f)(6)(D)(i) of the FD&C Act. Should you wish to propose additional accessories, your comment should identify each accessory's product code and/or classification regulation, and it should briefly explain why you think general controls alone will provide reasonable assurance of safety and effectiveness for the accessory if distinctly classified.\3\ Conversely, should you disagree with any of the proposed accessories for class I, your comments should briefly explain why additional regulatory controls, such as premarket review through a 510(k) submission or premarket approval (PMA), are necessary to provide reasonable assurance of safety and effectiveness. --------------------------------------------------------------------------- \3\ FDA's Product Classification Database for medical devices is online at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm. ---------------------------------------------------------------------------

IV. Proposed List of Accessories for Distinct Classification Into Class

I FDA is proposing the following accessories, which have been granted marketing authorization as part of a premarket submission (i.e., 510(k), De Novo classification request, or PMA) for another device with which they are intended to be used, as suitable for distinct classification into class I (see table 1). When FDA publishes the final list of accessories, after considering comments submitted for this proposed list and the factors in section II, FDA will consider those accessories classified into class I, distinct from other devices, through such action. For each distinct classification that is finalized as proposed, FDA would place a classification regulation for each of these accessories in 21 CFR part 870, 876, or 878, as appropriate. Each of these accessories would be class I, exempt from the premarket notification procedures in 21 CFR part 807, subject to the applicable limitations of exemption (i.e., 21 CFR 870.9, 876.9, or 878.9). FDA intends to make conforming changes to existing classification regulations for consistency and clarity, as appropriate. [[Page 53208]] Table 1--Proposed Accessories for Classification Into Class I and Distinct From Other Devices ---------------------------------------------------------------------------------------------------------------- Current classification regulation (21 Device type (existing CFR) product code) Proposed device type identification ---------------------------------------------------------------------------------------------------------------- Current Status of Accessory ---------------------------------------------------------------------------------------------------------------- 870.1130............................. Noninvasive blood A tube connecting the blood pressure cuffs to pressure measurement the noninvasive blood pressure measurement system accessories system. (DXN). 870.3610............................. Electrocardiogram cable Implantable pacemaker pulse electrocardiogram (DXY and OSR). cable accessories are cables used to transmit electrical signals between a pacing device and cardiac pacing leads or to connect the implantable pacemaker pulse generator system to compatible external equipment. They are not intended to power the implant or transmit energy to the implant. 870.4100............................. Extracorporeal membrane A non-electrical device that has no contact with oxygenation blood and that is used in an extracorporeal accessories (QJZ and membrane oxygenation circuit to support, QNR). adjoin, or connect components, or to aid in the setup of the extracorporeal line. Examples include but are not limited to an oxygenator mounting bracket or system-priming equipment. It is not intended to be used in transport environments. 870.5300............................. Auxiliary power supply An accessory used to charge the defibrillator (alternating current batteries when the defibrillator is not in use. or direct current) for low-energy direct- current defibrillator (MPD). 876.5130............................. Urological catheter Sterile plug used with a urological catheter to plug (KNY). seal the distal end of the catheter to prevent contamination of the catheter and/or leakage of urine from the catheter. 878.4400............................. Detachable suction Detachable plastic attachment at the distal end sleeve (GEI). of a smoke evacuating monopolar pencil that channels surgical smoke away from the surgical site. It is a single-use and sterile device. 878.4740 878.4750.................... Power charger accessory An accessory used to supply an electrical charge to a battery-powered to the battery. surgical instrument (GAG and GDW). ---------------------------------------------------------------------------------------------------------------- In addition, FDA received comments in response to the December 2025 request posted on our website suggesting that FDA distinctly classify reprocessing aids or tools, as well as percutaneous catheterization accessories. However, the suggestions did not identify product codes or classification regulations. Further, FDA has not separately identified such devices suitable for distinct classification. Information submitted in response to this notification that describes devices by referring to specific product codes may facilitate the identification and potential distinct classification into class I for such accessories.

V. Paperwork Reduction Act of 1995

While this document contains no new collection of information, it does refer to previously approved collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in the following table have been approved by OMB: ------------------------------------------------------------------------ OMB control 21 CFR Part; guidance; or FDA form Topic No. ------------------------------------------------------------------------ 807, subpart E.................... Premarket 0910-0120 notification. 814, subparts A through E......... Premarket approval.. 0910-0231 ``De Novo Classification Process De Novo 0910-0844 (Evaluation of Automatic Class classification III Designation)''. process. 800, 801, and 809................. Medical Device 0910-0485 Labeling Regulations. 820............................... Current Good 0910-0073 Manufacturing Practice (CGMP); Quality Management System Regulation (QMSR). ``Medical Device Accessories-- Medical Device 0910-0823 Describing Accessories and Accessories. Classification Pathways for New Accessory Types.''. ------------------------------------------------------------------------ [[Page 53209]] Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2026-16729 Filed 8-14-26; 8:45 am] BILLING CODE 4164-01-P