FDA Proposes Distinct Class I Classification for Seven Medical Device Accessories and Opens Public Comment

FDA Proposes Distinct Class I Classification for Seven Medical Device Accessories and Opens Public Comment

On August 17, 2026, the U.S. Food and Drug Administration (FDA), acting under the FDA Reauthorization Act (FDARA), issued a proposed notice proposing to classify seven types of medical device accessories into Class I (subject to general controls only). The accessories concerned are: non-invasive blood pressure measurement system accessories, electrocardiograph lead wires, extracorporeal membrane oxygenation (ECMO) accessories, ancillary power supplies for defibrillators, urological catheter plugs, removable suction sleeves, and battery chargers for surgical instruments. The proposal has been opened for public comment. If finalized, the accessories concerned would be exempt from premarket notification (510(k)) requirements, directly affecting the classification regulations, registration pathways, technical documentation, labelling and quality system compliance arrangements of manufacturers of these accessories.

This article is compiled from publicly available information published by FDA CDRH News & Updates. Source: https://www.federalregister.gov/d/2026-16729. Specific requirements are subject to the regulator's latest official publications.

Source and Applicability Notes

• Source organization: FDA CDRH News & Updates
• Original publication date: August 13, 2026
• Article date: August 17, 2026
• Information collected on: 2026-08-18T02:49:13.251Z
• Article published on: 2026-08-18 15:41
• Article source: FDA CDRH News & Updates

This article is compiled from publicly available information published by FDA CDRH News & Updates. Source: https://www.federalregister.gov/d/2026-16729. Specific requirements are subject to the regulator's latest official publications.

Full Translation of the Original Notice

Federal Register: Medical Devices; Distinct Classification of Accessories and Other Devices; Proposed List Suitable for Class I Classification; Request for Comments

Agency: Department of Health and Human Services, Food and Drug Administration.

Action: Notice; request for comments.

Summary: As required by the FDA Reauthorization Act of 2017 (FDARA), FDA has identified a list of accessories for which the Agency believes that general controls alone would provide reasonable assurance of safety and effectiveness, and which are therefore suitable for classification into Class I. FDA is publishing this document to propose classifying these accessories into Class I distinct from other devices, and to solicit public comment in accordance with the process established by FDARA. This document does not constitute FDA's final determination on the proposed accessories listed.

Dates: Electronic or written comments on this notice must be submitted by October 16, 2026.

Addresses: Comments may be submitted as follows.

Please note that late comments will not be considered.

• Electronic submissions: https://www.regulations.gov. Follow the instructions for submitting comments. The electronic submission system will accept comments until 11:59 p.m. Eastern Time at the end of October 16, 2026. Written/paper comments submitted by mail, in person, or by courier will be considered timely if received on or before that date. Comments submitted electronically to https://www.regulations.gov, including attachments, will be posted to the docket as submitted. Because your comment will be made public, you are responsible for ensuring that it does not contain any confidential information that you or a third party may not wish to be made public, such as medical information, your own or another person's Social Security number, or confidential business information such as manufacturing processes. Please note that if you include your name, contact information or other information identifying you in the body of your comment, that information will be posted on https://www.regulations.gov. If you wish to submit a comment containing confidential information that you do not want to be made public, submit it in written/paper form and follow the detailed instructions (see Written/Paper Submissions and Instructions).
• Written/paper submissions: Mail, in person or 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 and any attachments, except for material submitted, marked and identified as confidential in accordance with the detailed provisions in the Instructions.

Instructions: All submissions must include the docket number FDA-2025-N-6224, corresponding to Medical Devices; Distinct Classification of Accessories and Other Devices; Proposed List Suitable for Class I Classification; Request for Comments. Timely comments received (see Addresses) will be placed in the docket and, except for those submitted as Confidential Submissions, will be available for public viewing at https://www.regulations.gov or at the Dockets Management Staff (Monday to Friday, 9 a.m. to 4 p.m., telephone 240-402-7500).

If you wish to submit comments containing confidential information that you do not want to be made public, submit them in written/paper form and follow the detailed instructions (see Written/Paper Submissions and Instructions). One copy will include the information you claim to be confidential, with a heading or cover note stating that the document contains confidential information. The second copy will have the claimed confidential information deleted or redacted, for public review and posting.

If you do not wish your name and contact information to be made public, you may place this information on a cover page rather than in the body of the comment, and you must identify this information as confidential.

For more information about how FDA posts comments to the public docket, see the Federal Register of September 18, 2015 (80 FR 56469).

Docket: To access the docket to read background documents or electronic and written/paper comments received, go to https://www.regulations.gov, enter the docket number found in brackets in the heading of this document in 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) provides a process for classifying certain medical devices, namely accessories, separately from the parent device or device system with which the accessory is intended to be used. FDA refers to this process as distinct classification. It derives 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 solicits public comment on the proposal. This notice is a periodic proposal issued under Section 513(f)(6)(D)(i) of the FD&C Act, and FDA is seeking feedback through public comment. This notice follows FDA's December 5, 2025 request for public comment posted on its website regarding which accessories to consider for distinct classification, which informed the preparation of this document.

Legal Authority

The accessories addressed in this proposal are devices regulated under the FD&C Act. Specifically, Section 201(h) of the FD&C Act defines device to include accessories (see 21 U.S.C. 321(h)). An accessory is a device, and all items meeting the definition of device are regulated under the FD&C Act. FDA has described its current thinking on which devices it generally regards as accessories in the guidance document Medical Device Accessories - Describing Accessories and Classification Pathways (the Accessory Guidance). Based on Sections 201(h) and 513(f)(6) of the FD&C Act, the guidance 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 the class reflecting the level of regulatory control necessary to provide reasonable assurance of safety and effectiveness. Section 513 of the FD&C Act defines three device classes: Class I (general controls), Class II (special controls) and Class III (premarket approval). Because an accessory may obtain marketing authorization as part of a submission for another device with which it is intended to be used, commonly referred to as the parent device or device system, an accessory may be subject to controls beyond general controls because of the parent device or device system. However, for certain such accessories, general controls alone may be sufficient to provide reasonable assurance of safety and effectiveness when the accessory is considered separately from the parent device or device system.

Under Section 513(h)(1) of the FD&C Act, general controls are the controls authorized or prescribed by 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 relating to adulteration and misbranding, registration and listing, device records and reports, and good manufacturing practices. The good manufacturing practice provisions in 21 CFR Part 820, Quality Management System Regulation, include design and development control requirements for the manufacture of certain devices. However, design and development control requirements generally do not apply to Class I devices, other than devices identified in 820.10(c)(2) (21 CFR 820.10(c)(2)) and devices automated with computer software.

FDA is issuing this document under the legal authority discussed in this notice and is providing the public with an opportunity to comment on the proposal. After the comment period closes, FDA will consider the comments and publish a final action in the Federal Register classifying suitable accessories into Class I distinct from other devices, as appropriate.

Considerations

The classification of each accessory will be based on the risk of the accessory when used as intended and the level of regulatory control necessary to provide reasonable assurance of safety and effectiveness, regardless of the classification of any other device with which the accessory is intended to be used (see Section 513(f)(6)(A) of the FD&C Act).

In general, FDA considers an accessory eligible for distinct classification into Class I, separate from other devices, if the accessory: (1) is not intended to support or sustain human life or to be of substantial importance in preventing impairment of human health (see 21 CFR 860.3, which defines terms such as life-supporting or life-sustaining device); (2) does not present a potential unreasonable risk of illness or injury; and (3) is one for which general controls alone are sufficient to provide reasonable assurance of safety and effectiveness.

Please note that, under the regulation, design and development controls apply only to Class I devices automated with computer software or listed in 820.10(c)(2). Accordingly, if an accessory is not automated with computer software but requires design controls to provide reasonable assurance of safety and effectiveness, FDA does not consider it eligible for distinct classification through this process.

Similarly, a device-specific accessory is an accessory designed for use with a particular parent device and/or device system based on unique dimensions, geometry and/or deployment. In these cases, design specifications are critical to the correct use of the accessory in supporting, supplementing and/or augmenting the performance of the parent device and/or specific system. For such device-specific accessories, design and development controls are an important factor in ensuring appropriate compatibility between the accessory and the parent device and/or system, and therefore device-specific accessories are generally not eligible for distinct classification through this process. FDA set out this rationale for device-specific orthopedic devices in the Federal Register of August 17, 2018 (83 FR 41023, 41025-26), and subsequently adopted it in the Federal Register of April 12, 2019 (84 FR 14865, 14869). The same principles and definitions apply to this proposal.

You may use the factors described above to propose additional accessories suitable for distinct classification into Class I, provided that those accessories meet the criteria for classification under Section 513(f)(6)(D)(i) of the FD&C Act. If you wish to propose additional accessories, your comment should identify the product code and/or classification regulation for each accessory and briefly explain why you believe general controls alone would provide reasonable assurance of safety and effectiveness for the separately classified accessory. Conversely, if you disagree with any proposed Class I accessory, your comment should briefly explain why additional regulatory controls, for example premarket review through a 510(k) submission or premarket approval (PMA), are needed to provide reasonable assurance of safety and effectiveness.

List of Accessories Proposed for Distinct Classification into Class I

FDA proposes that the following accessories, which have already received marketing authorization as part of a premarket submission for another device, namely a 510(k), a De Novo classification request, or a PMA, where that device is the parent device with which the accessory is intended to be used, are suitable for distinct classification into Class I (see Table 1). When FDA publishes the final list of accessories after considering comments submitted on this proposed list and the factors in Part II, FDA will through that action consider classifying these accessories into Class I, distinct from other devices.

For each distinct classification finalized as proposed, FDA will, as appropriate, place the classification regulation for each accessory in 21 CFR Parts 870, 876 or 878. Each of these accessories will be Class I, exempt from the premarket notification procedures in 21 CFR Part 807, subject to the applicable limitations of exemptions, namely 21 CFR 870.9, 876.9 or 878.9. FDA intends to make conforming changes to existing classification regulations as appropriate to maintain consistency and clarity.

Table 1 - Accessories Proposed for Distinct Classification into Class I, Separate from Other Devices

• 1. Current classification regulation: 870.1130; Device type (existing product code): Non-invasive blood pressure measurement system accessories (DXN); Proposed device type identification: Tubing that connects a blood pressure cuff to a non-invasive blood pressure measurement system.
• 2. Current classification regulation: 870.3610; Device type (existing product codes): Electrocardiograph lead wires (DXY and OSR); Proposed device type identification: Implantable pacemaker pulse electrocardiograph lead wire accessories are cables used to transmit electrical signals between a pacing device and cardiac pacing leads, or to connect an implantable pacemaker pulse generator system to compatible external equipment. They are not intended to power the implant or transfer energy to the implant.
• 3. Current classification regulation: 870.4100; Device type (existing product codes): Extracorporeal membrane oxygenation accessories (QJZ and QNR); Proposed device type identification: A non-electrical device that does not contact blood, used in an extracorporeal membrane oxygenation circuit to support, abut or connect components, or to help establish the extracorporeal circuit. Examples include, but are not limited to, oxygenator mounting brackets or system priming devices. Not intended for use in the transport environment.
• 4. Current classification regulation: 870.5300; Device type (existing product code): Ancillary power supplies (AC or DC) for low-energy DC defibrillators (MPD); Proposed device type identification: An accessory used to charge defibrillator batteries when the defibrillator is not in use.
• 5. Current classification regulation: 876.5130; Device type (existing product code): Urological catheter plugs (KNY); Proposed device type identification: A sterile plug used with a urological catheter to seal the distal end of the catheter to prevent contamination of the catheter and/or leakage of urine from the catheter.
• 6. Current classification regulation: 878.4400; Device type (existing product code): Removable suction sleeves (GEI); Proposed device type identification: A removable plastic accessory located at the distal end of a smoke-evacuation monopolar electrosurgical pencil that evacuates surgical smoke away from the surgical site. It is a single-use sterile device.
• 7. Current classification regulations: 878.4740 and 878.4750; Device type (existing product codes): Power charger accessories for battery-powered surgical instruments (GAG and GDW); Proposed device type identification: Accessories used to charge battery-powered devices.

In addition, FDA received comments in response to the request posted on its website in December 2025 recommending that FDA apply distinct classification to reprocessing aids or tools and to percutaneous catheter insertion accessories. However, those recommendations did not identify a product code or classification regulation. In addition, FDA has not separately determined that such devices are suitable for distinct classification. Information describing devices by reference to specific product codes in response to this notice may help to identify such accessories and potentially classify them distinctly into Class I.

Paperwork Reduction Act of 1995

Although this document does not contain a new information collection, it does refer to previously approved information collections. The previously approved information collections 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 information collections in the table below have been approved by OMB:

• 21 CFR Part 807, Subpart E: Premarket Notification, OMB Control No. 0910-0120;
• 21 CFR Part 814, Subparts A through E: Premarket Approval, OMB Control No. 0910-0231;
• De Novo Classification Process (Evaluation of Automatic Class III Designation): De Novo Classification Process, OMB Control No. 0910-0844;
• 21 CFR Parts 800, 801 and 809: Medical Device Labeling Regulations, OMB Control No. 0910-0485;
• 21 CFR Part 820: Current Good Manufacturing Practice (CGMP); Quality Management System Regulation (QMSR), OMB Control No. 0910-0073;
• Medical Device Accessories - Describing Accessories and Classification Pathways for New Accessory Types: Medical Device Accessories, OMB Control No. 0910-0823.

Signature: Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Footnotes

• 1. Available at https://www.fda.gov/medical-devices/classify-your-medical-device/cdrh-seeks-public-comment-identifying-accessories-suitable-distinct-classification-class-i-devices. A copy is also available in the public docket. FDA verified the website addresses in this document as of the date of publication in the Federal Register, but websites may change over time.
• 2. Available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM429672.
• 3. FDA's medical device product classification database is available online at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm.

[FR Doc. 2026-16729, filed August 14, 2026 at 8:45 a.m.] BILLING CODE 4164-01-P

What Does This Information Mean for Medical Device Companies?

Information of this kind issued by FDA CDRH News & Updates should first be brought into a company's regulatory intelligence and post-market surveillance scope, rather than being read merely as general news. Companies need to determine whether the update is a guidance document, a recall or safety communication, a product approval, digital health information, a quality system item or post-market regulatory information, and to confirm whether it affects existing registration projects or products under development.

If the content concerns a specific product, test performance, a risk warning or a regulatory measure, companies should further assess whether it affects product classification, the 510(k), De Novo or PMA pathway, technical documentation, labelling and instructions for use, quality system records or post-market reporting obligations. Companies pursuing U.S. market registration should record the source link, publication date, scope of application and internal conclusions in the project log.

Which Materials Should Companies Prioritise for Review?

It is advisable to review the basis for product classification, applicable regulatory provisions, predicate device or substantial equivalence determinations, performance testing, software and cybersecurity documentation, risk management, clinical evidence, labelling and instructions for use, and quality system readiness.

Common Risks

Common risks include misjudging the FDA pathway, overlooking changes in guidance documents, insufficiently designed performance testing, overly broad labelling claims, unclear post-market reporting obligations, and applying documentation prepared for other markets directly to U.S. registration.

AIMEILI Regulatory Interpretation and Business Impact

The proposed list of distinctly classified accessories published by FDA under the FDA Reauthorization Act may appear at first glance to be no more than the removal of seven common low-risk accessories from the premarket review system of their parent devices, but its impact on the medical device regulatory ecosystem is considerable. For Chinese medical device companies, particularly those supplying U.S. customers on an OEM/ODM basis with accessories such as non-invasive blood pressure measurement system tubing, electrocardiograph lead wires, ECMO mounting brackets, defibrillator chargers, urological catheter plugs, smoke-evacuation electrosurgical suction sleeves and battery chargers for surgical instruments, the first step is to confirm whether their products fall within the scope of the list, and to monitor whether the proposed rule can be finalized smoothly after the comment period closes on October 16, 2026.

Once the final rule takes effect, the classification of these accessories will shift from a pathway dependent on the parent device through a 510(k), De Novo or PMA to an independent Class I classification with a general exemption from the premarket notification requirements in 21 CFR Part 807. This means that the registration cost and timeline for bringing the relevant products to the U.S. market can be expected to fall significantly.

Registration Pathway Considerations

From a registration pathway perspective, Chinese manufacturers need to recognise that a Class I classification does not mean that no compliance action is required. FDA states clearly in the notice that, after final classification, each accessory must still comply with the applicable limitations of exemptions, such as 21 CFR 870.9, 876.9 or 878.9, and must satisfy general controls including registration and listing, labelling, adverse event reporting and the quality system requirements under the QMSR.

In other words, companies will still need to complete listing in the FDA establishment registration and device listing system, still need to establish a quality management system compliant with 21 CFR Part 820, still need to appoint a U.S. agent, and must maintain post-market surveillance and reporting obligations. For accessory manufacturers that previously relied on the parent device's 510(k) for market access, it will be necessary to reassess their registration strategy once the final rule takes effect, so as to avoid problems such as inaccurate listing, outdated labelling, or quality system documentation that no longer matches the classification status of the product.

Impact on Technical Documentation and Clinical Evaluation

The impact on technical documentation and clinical evaluation should not be overlooked either. Most of the accessories in the proposed list are passive, single-use, non-electrical components or components used only for supporting functions, and FDA considers that they do not require design and development controls and are not life-supporting or associated with a potential unreasonable risk. However, companies cannot assume that all accessories will qualify for Class I.

FDA specifically emphasises that device-specific accessories are generally not eligible for distinct classification, because the compatibility of their design specifications with a particular parent device is critical to safety and effectiveness. This means that if an accessory manufactured by a Chinese company is customised for the specific device of a particular U.S. customer, or depends on particular dimensions, geometry or a release mechanism, then even if its risk is low, it may not benefit from the Class I exemption and may still require premarket review through a 510(k), De Novo or similar pathway. Companies should therefore carefully compare the design logic and intended use of their products, determine whether they are general accessories or device-specific accessories, and prepare the corresponding classification regulation basis, product codes and supporting documentation accordingly.

Quality System, Labelling and Product Codes

From the perspective of the quality system and labelling, FDA notes in the notice that, among Class I devices, only products automated with computer software or listed in 820.10(c)(2) are subject to design and development control requirements. In practice, this is a reminder to Chinese manufacturers that if an accessory contains no software itself but has had simple electronic control or data processing functions added for market compliance reasons, this may trigger design control requirements and therefore remove the product's eligibility for Class I classification through this rule.

For companies already selling the relevant products on the U.S. market, they should promptly check their FDA listing information, product labels and intended use descriptions against the product codes for each accessory type in the proposed list, such as DXN, DXY, OSR, QJZ, QNR, MPD, KNY, GEI, GAG and GDW, to confirm consistency with the proposed device type identification. Where inconsistencies exist, labels, instructions for use and 510(k) exemption statements may need to be adjusted to avoid compliance risk.

Engaging with the Comment Process

In addition, FDA notes in the notice that earlier comments recommending distinct classification for reprocessing aids and tools and for percutaneous catheter insertion accessories were set aside because no product code or classification regulation was provided. This sends a clear signal to Chinese medical device companies: if a company wishes to promote the entry of additional competitive accessory products manufactured in China into U.S. Class I classification, it should actively use FDA's public comment mechanisms and do the groundwork on product codes, classification regulations and justification that general controls are sufficient, submitting formal recommendations through professional regulatory channels.

Aimeili recommends that Chinese manufacturers not only focus on the products within this list, but also review all accessory-type devices they export to the United States across their product portfolio, assess whether they meet the three conditions for distinct Class I classification, and plan ahead for possible future regulatory changes. For products already on the market, companies should assess before October 16, 2026 whether a comment should be submitted or the U.S. registration strategy adjusted; for products under development, the classification pathway should be considered early in the development process so that budgets and timelines can be planned appropriately.

FAQ

Does an update on an FDA public page always represent a regulatory change?

No. It is necessary to distinguish between news items, guidance documents, database pages, recall information and formal regulatory documents. Where the content is significant, companies should return to the original FDA source and the applicable regulations before drawing conclusions.

What should a company do after seeing an FDA update?

First determine whether it affects product classification, the registration pathway, technical documentation or post-market obligations, and then decide whether the project plan needs to be updated.

Content Review and Scope of Application

• Author: Aimeili Regulatory Editorial Team
• Professional review: Aimeili Medical Device International Registration Project Team
• Source principles: Priority is given to official regulatory authorities, international organizations, standards bodies and publicly available regulatory materials; industry media and project experience are used only as supporting references.
• Scope of application: This article is intended for preliminary understanding, documentation preparation and project planning. It does not replace the formal requirements of the regulatory authority of the target country, testing conclusions or legal advice.

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