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CDRH Seeks Public Comment: Identifying Accessories Suitable for Distinct Classification as Class I Devices

To prepare for an upcoming regulatory action to place suitable accessories (medical devices) in class I, the U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) is requesting public input regarding which accessories to consider for “distinct classification.” Accessories suitable for distinct classification in Class I are those that (1) already have marketing authorization (are “existing accessories”) and (2) are devices for which general controls are sufficient to provide reasonable assurance of safety and effectiveness.1

This Request for Public Comment is a preliminary step to help CDRH identify suitable accessories for distinct classification into class I and is intended to seek early feedback from groups and individuals outside the Agency. CDRH intends to consider all relevant comments submitted within 90 days, on or before March 5, 2026, to develop a proposal for the distinct classification action.

Background

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines the term “device” to include an “accessory” (see section 201(h)(1) of the FD&C Act). FDA considers an accessory to be a finished device that is intended to support, supplement, and/or augment the performance of another device, sometimes called a “parent device,” or as part of a device system. See FDA’s guidance, “Medical Device Accessories—Describing Accessories and Classification Pathways” (the “Accessory Guidance”) for more information.2  Existing accessories are devices already authorized for marketing, either as class III (approved as part of a premarket approval application) or class II (for example, through a De Novo request or premarket notification, often called a “510(k)”).3

Existing accessories have sometimes been classified as part of (not distinct from) the parent device or system of devices. For example, the devices’ sponsor may have described the accessory in a De Novo classification request for the parent device, leading to a single classification that includes the parent and accessory devices together. However, in some cases, an accessory may be appropriately classified separately from the parent or system, in class I. In such cases, establishing a distinct classification for the accessory may reduce the regulatory burden associated with marketing the accessory without compromising the reasonable assurance of safety and effectiveness.

The FDA Reauthorization Act of 2017 established a process for FDA to periodically propose a list of accessories suitable for distinct classification into class I (Pub. L. 115-52; 131 Stat. 1061; see section 513(f)(6)(D)(i) of the FD&C Act). After considering public comments, FDA intends to classify accessories suitable for distinct classification into class I, if any.

Factors to Consider

Certain factors influence whether accessories may be suitable for distinct classification into class I. FDA encourages comments that address these factors, which may be more persuasive than comments that propose or identify a device without speaking to these factors. In general, an accessory may be suitable for distinct classification into class I if:

  1. The accessory is not for use in supporting or sustaining human life, and is not of substantial importance in preventing impairment to human health;
  2. The accessory does not present a potential unreasonable risk of illness or injury;
  3. General controls alone are sufficient to provide a reasonable assurance of safety and effectiveness of the accessory.
  4. As part of considering general controls:
    • Design controls are not necessary for reasonable assurance of safety and effectiveness (so the automatic removal of the design-control requirement once in class I would not compromise reasonable assurance); or
    • Design controls are necessary for reasonable assurance of safety and effectiveness, but the accessory is automated with computer software (so the requirement for design controls would continue to apply for the accessory even if class I).4

Any classification of an existing accessory is based on the risks of the accessory when used as intended and the level of regulatory controls necessary to provide 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).5

The factors that FDA considers to determine whether accessories may be suitable for distinct classification into class I are consistent with section 513 of the FD&C Act, which sets forth device classifications to reflect the level of regulatory controls necessary to provide reasonable assurance of safety and effectiveness. Class I devices are those for which general controls are sufficient to provide reasonable assurance of safety and effectiveness (see section 513(a)(1)(A)(i) of the FD&C Act).

To determine if an accessory is suitable for distinct classification into class I, we specifically consider whether design controls (general controls authorized under section 520 of the FD&C Act) are necessary to provide reasonable assurance of safety and effectiveness. Manufacturers are generally not required to establish design controls for class I devices, with one relevant exception: when the device is automated with computer software (see 21 CFR 820.30(a) 6). Thus, if design controls are necessary to demonstrate reasonable assurance of safety and effectiveness of the accessory, but the requirements for such controls would automatically cease to apply were the device placed in class I, then the accessory would not be suitable for distinct classification in class I.

Request for Public Comment

We request your comments on existing accessories that may (or may not) be suitable for distinct classification in Class I. Comments that describe how general controls would (or would not) be sufficient to address the risks of the device when used as intended would likely be more persuasive than comments that only list existing accessories. Similarly, comments that discuss why design controls are not (or are) necessary would likely be more persuasive than comments that do not discuss design controls.

Commenters who opt to respond need not discuss all these considerations and may choose to address, for example, only those considerations for which they have expertise, experience, or insight. Similarly, responses need not address every regulatory control individually.

For this Request for Public Comment, please submit any comments on or before March 5, 2026 to https://www.regulations.gov, Docket No. FDA-2025-N-6224 for “Distinct Classification of Accessories in Class I (2025).” Comments submitted in response to this Request for Public Comment will be publicly available online, so you should not include confidential information about yourself or others in the body of the comment. You are solely responsible for ensuring the content of your comment to regulations.gov does not include any confidential information (or other information that you do not wish to be publicly visible). If you wish to send FDA confidential information, then before submitting a comment to regulations.gov, please contact us at the email address provided for further guidance.

Questions

For questions, contact CDRH-Accessories@fda.hhs.gov .

  1. 1 General controls are those controls authorized by or under the following sections of the FD&C Act: Section 501, regarding adulterated devices; 502, misbranded devices; 510, registration of device producers (and other parties) and listing of devices; 516, banned devices; 518, notification and other remedies for devices; 519, records and reports on devices; and/or 520, general provisions respecting control of devices intended for human use. See Section 513(h)(1) of the FD&C Act (21 U.S.C. 360c(h)(1)).
  2. 2 This guidance also describes FDA’s policy for initial classification of accessories. Note that a product that is not considered a medical device under the FD&C Act is not within the scope of this action. For example, a general-use personal computer (that is not a medical device) is not an “accessory” within the scope of this action, even though it might support or augment the use of a medical device.
  3. 3 See the Accessory Guidance.
  4. 4 See the prior final classification action of April 12, 2019 (84 FR 14865).
  5. 5 See also the Accessory Guidance.
  6. 6 On February 2, 2024, FDA published a final rule amending 21 CFR part 820 (89 FR 7496), which will become effective on February 2, 2026. The regulation that sets forth requirements for design and development controls will then be 21 CFR 820.10(c). Note that the final classification action for which we are requesting public comment will not also expand the Class I devices for which manufacturers must establish design and development controls.
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