The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) requested public comments on medical device accessories that could be independently classified as Class I devices. The proposal covers accessories that already have marketing authorization, and the agency believes that general controls alone may be sufficient to provide reasonable assurance of their safety and effectiveness.
CDRH published the proposed list in the Federal Register after an early stage of gathering input and plans to consider relevant comments submitted within 60 days, with the deadline set for October 16, 2026. After reviewing the submissions, the agency will determine whether to independently classify any of these accessories as Class I devices.
What Are Existing Accessories?
FDA defines an accessory as a finished device intended to support, supplement, or augment the performance of another device, or to be used as part of a system of devices. An accessory may be classified with the primary device or system as a whole rather than having a separate classification.
This process applies to existing accessories that have previously received marketing authorization, whether as part of Class III devices through a premarket approval application, or as part of Class II devices through the De Novo pathway or the premarket notification process known as 510(k). FDA explains that the proposed classification is based on the risks of the accessory when used as intended, rather than automatically on the classification of the device with which it operates.
Criteria FDA Will Consider
The agency believes that an accessory may be suitable for independent classification as a Class I device if it is not intended to support or sustain life, is not of substantial importance in preventing impairment of human health, and does not present an unreasonable risk of illness or injury. General controls must also be sufficient to provide reasonable assurance of safety and effectiveness.
FDA encourages participants to explain how these controls address risks under the intended use, rather than merely identifying specific devices or accessories. Comments discussing whether design controls are needed, or why they are not needed, may be more useful in the evaluation process.
What Changes in Practice?
Independent classification of certain accessories could reduce the regulatory burden associated with marketing them without abandoning the level of assurance required for safety and effectiveness. However, this would not automatically apply to every accessory, and Class I status may not be appropriate if design controls are necessary to ensure its performance.
FDA explains that design controls are generally not required for Class I devices, with a relevant exception for automated devices that rely on software. If design controls are necessary for the accessory’s safety and effectiveness and would automatically cease to apply when it is transferred to Class I, the accessory may not be eligible for independent classification. If an automated accessory relies on software, design-control requirements may continue to apply even if it is classified as Class I.
Deadline and Participation Process
Comments may be submitted through Regulations.gov before October 16, 2026, using docket number FDA-2025-N-6224 and the action title “Distinct Classification of Accessories in Class I (2025).” Submitted comments will become publicly available, so FDA cautions against including confidential information or data that the participant does not want published. For inquiries, CDRH has designated the email address CDRH-Accessories@fda.hhs.gov.
certi.news reading: The current step is neither a final classification decision nor an announcement of a blanket exemption for accessories. Rather, it is a regulatory stage that could affect future marketing pathways for certain existing devices. The practical value for manufacturers and developers will lie in comparing the risks of the accessory itself with the controls it requires, with particular attention to the role of software and design controls. The source material does not provide details about the accessories included in the proposed list, limiting the ability to assess its impact on particular products before the final decision is issued.