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A primer on FDA’s accessories classification process and regulatory confusion

Under the FDA Reauthorization Act of 2017, the FDA was directed to establish a process for classifying medical device accessories separately from their parent devices. In implementing that process in 2019, the agency distinguished between “general use” and “device-specific” orthopedic instruments, a distinction that affects whether an accessory may qualify for a separate Class I classification. The FDA recently published a proposed list of accessories for Class I classification and a new webpage explaining the relevant criteria, suggesting that it may apply this approach more broadly.

By Laura DiAngelo, MPH | Sep 3, 2026 5:37 PM EDT

FDA’s regulatory systems for device accessories

  • What is an accessory? A medical device is any “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory” (emphasis added) intended for use as a medical product, according to the Federal Food, Drug and Cosmetic Act. An accessory is defined as a “finished device that is intended to support, supplement, and/or augment the performance of one or more parent devices.” An accessory can be authorized as part of a parent device’s submission or receive its own distinct regulatory classification. An accessory that is included in the parent device’s submission and receives the same risk-based classification will be regulated under that classification. For example, if a surgical implement accessory is included and approved with the Premarket Approval application of the orthopedic implant parent device, that implement is a Class III medical device along with the implant. Alternatively, a standalone general surgical instrument would be a Class I exempt device.
  • The FDA’s process for accessories got a refresh under the FDA Reauthorization Act of 2017. That law directed the FDA to consider accessories separately from the parent device, with classification of the accessory “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.” The update followed concerns that the packaging of accessories into the marketing submission for the parent device was unduly burdensome for accessories. Historically, the FDA had considered accessories to be Class I exempt devices. Before FDARA, however, the agency began expecting accessory information in a parent device’s premarket submission. The FDA would then classify the accessory with the parent device. As a result, accessories increasingly received Class II or Class III classifications, regardless of the accessory’s own risk profile.
  • FDARA created a mechanism for sponsors to request a different classification for an accessory than the parent device. In its implementing guidance, the agency explained the rationale for what it called an Accessory Classification Request by acknowledging that “some accessories can have a lower risk profile than that of their parent device and, therefore, may warrant being regulated in a lower class. For example, an accessory to a class III parent device may pose lower risk that could be mitigated through general controls or general and special controls and thus could be regulated as class I or class II.”
  • The FDA’s 2017 guidance offers an explainer on what the agency considers to be an “accessory” and its thinking on the risk-based framework. The device-classification process, defined in Section 513 of the FD&C Act, includes processes for both initial accessory classification and reclassification. Reclassification applies when an accessory is already classified with its parent device but the sponsor or FDA believes it may be eligible for a lower risk classification. In that case, a sponsor would submit an Existing Accessory Request as a standalone request, not packaged with a PMA or a 510(k) application. A New Accessory Request is part of the marketing submission. Alternatively, a sponsor can submit a De Novo request for a new accessory type, but this is subject to the De Novo user fee.
  • The 2017 guidance includes two criteria for classifying accessories: “1. Is the article an accessory? 2. What is the risk of the accessory when used as intended with the parent device(s) and what regulatory controls are necessary to provide a reasonable assurance of its safety and effectiveness?” The guidance explains, “The answers to these two questions inform the risk- and regulatory control-based classification of a potential accessory pursuant to the criteria” under Section 513. The document then defines what makes a device an accessory and how to consider the risks.

Accessories as Class I and a 2019 ‘policy clarification’

  • FDARA directed the FDA to establish a process to designate appropriate accessories as Class I devices and build a system to reclassify accessories that were Class II or Class III into Class I. The agency issues lists of accessories by product code that may be suitable for distinct classification into Class I.
  • As part of the inaugural list of accessories suitable for distinct classification, published in 2018, the FDA listed “factors for consideration” for moving accessories into Class I exempt status apart from their parent devices. The agency wrote that it considers an accessory eligible for such classification if it “(1) Is not for use in supporting or sustaining human life, or of substantial importance in preventing impairment to human health; (2) does not represent 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.”
  • This notice, finalized in 2019, also included a “policy clarification” on eligibility for the accessory classification process. The FDA explained a regulatory approach for certain accessories used in orthopedic surgery. Historically, manual orthopedic surgical instruments have been regulated as Class I exempt products under 21 CFR 878.4800 or 21 CFR 888.4540, although some products have their own specific regulatory classifications. However, as the FDA increasingly expected accessory information to be included in the parent device’s marketing submission, more accessories were classified as Class II or Class III devices based on the parent device, creating the problem FDARA intended to address.
  • In its 2019 notice, the FDA differentiated between “device-specific” and “general use” accessories for orthopedics. According to the notice, a device-specific orthopedic instrument “is considered to be an accessory designed specifically for appropriate implantation or placement of the parent device, based upon unique dimensions, geometry, and/or deployment.” Therefore, 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 a specific system.” Device-specific accessories are not eligible for Class I exempt status because the agency asserted that they require design controls, which Class I general controls do not cover.
  • There is an exception: software-automated devices. Under the regulations then in effect, “design controls apply to class I devices only if the devices are automated with computer software” or are otherwise subject to design controls under Section 820.30. (Note: Section 820.30 in 2019 was part of the Quality System Regulation; the QSR was replaced by the Quality Management System Regulation on Feb. 2, 2026.) The FDA’s 2019 policy said that, among accessories subject to design controls, only those automated with software could qualify for Class I status through this process.
  • Industry flagged concerns with the interpretation. AdvaMed noted in its comments that FDARA does not differentiate between device-specific and general-use accessories. Therefore, the trade association asserted that it does “not believe this Policy Clarification is necessary or consistent with law.” AdvaMed cited the FDARA provision stating that device accessories should be classified based on the risks of the accessory “notwithstanding the classification of any other device with which such accessory is intended to be used.” The group said the FDA’s policy directly conflicts with the law by using a differentiation of accessories based on the devices for which they are intended to be used. The association did acknowledge that some device-specific accessories may be ineligible to be regulated as Class I exempt products because of the need for design controls, but it argued that this assumption should not be applied across the board. Instead, AdvaMed said the agency should revert to a system of considering “all manual surgical instruments” as Class I exempt products or “provide a detailed description and justification for each device type that explains the Agency’s rationale.” The Orthopedic Surgical Manufacturers Association expressed similar confusion, noting that “these ‘device-specific’ instruments have never been formally defined by FDA either through Guidance or Regulation.” So OSMA asked the agency to revert to its previous practice of treating all manual surgical instruments provided with Class II or Class III orthopedic implant systems as Class I exempt devices.
  • The FDA disputed industry’s characterization of the policy as inconsistent with FDARA. “This policy clarification does not impose new regulatory requirements upon devices that had previously been cleared or approved, but rather provides transparency for the Agency’s existing policy concerning classification of certain orthopedic accessories,” the final notice states. The agency said the clarification was intended to better “explain the limited scope of accessories that would be appropriate for distinct classification” and to “provide clarity regarding accessories that fit within existing class I classification regulations.”

A new accessories list raises the question again

  • The FDA has proposed a list of accessories that could qualify for Class I exempt status separately from their parent devices. The list, published Aug. 17, 2026, covers eight regulatory citations and 10 product codes and is open for comment through Oct. 16.
  • The FDA posted a webpage Aug. 26 explaining how it considers the criteria classifying accessories as Class I devices. The notice and webpage highlight a continuing source of confusion: What exactly are the criteria, and how are they applied?
  • The proposed accessories list sets out the three “factors for consideration” for determining an accessory’s eligibility established in the 2018 notice: (1) The accessory “is not for use in supporting or sustaining human life, or of substantial importance in preventing impairment to human health”; (2) It “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.”
  • The webpage, however, adds a fourth factor. An accessory may qualify for Class I exempt status if design controls are not necessary to provide reasonable assurance of safety and effectiveness. If design controls are necessary, an accessory may still qualify if it is automated with computer software. The webpage cites the 2019 policy clarification for orthopedic devices in its discussion of this fourth factor, linking the current framework to the agency’s earlier interpretation.
  • The new list and webpage indicate that the agency is expanding its thinking on device-specific versus general-use accessories. While the 2019 policy clarification focused only on orthopedic instruments, the new Federal Register notice states that the agency is applying the concept more broadly. The FDA singled out accessories specific to parent devices or systems whose “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.” It then refers to the 2019 notice and says, “The same principle and definition apply to this proposal.”
  • The proposal is likely to generate additional comments, particularly on the agency’s assertion that device-specific accessories generally do not qualify for Class I status and its extension of the 2019 policy clarification’s rationale beyond orthopedic instruments. In industry’s view, this approach would limit the number of accessories eligible for distinct Class I classification. The issue also revives a concern OSMA raised in 2018: that an accessory’s regulatory classification may depend on when it was introduced, which review process was in use at the time, and the device or system with which it is used. That concern reflect the FDA’s evolving approach – from treating manual orthopedic instruments as Class I exempt, to classifying accessories with their parent devices, to separating accessories from parent devices under FDARA.

To contact the author of this item, please email Laura DiAngelo ( ldiangelo@agencyiq.com).
To contact the editor of this item, please email Jason Wermers ( jwermers@agencyiq.com).

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