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. L. 115-52). Under section 513(f)(6)(D)(i) of the FD&C Act as amended by FDARA (21 U.S.C. 360c(f)(6)(D)(i)), FDA periodically proposes accessories that may be suitable for distinct classification into class I and seeks public comment on the proposal. This notification is a periodic proposal pursuant to section 513(f)(6)(D)(i) of the FD&C Act, and FDA is seeking feedback on this proposal through public comment. This notification follows a request for public input regarding which accessories to consider proposing for distinct classification that FDA posted on its website on December 5, 2025, to develop this document.^[1]

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.”

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 ( printed 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 § 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 § 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.

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. ( printed page 53208)

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:

91 FR 53205