2026-10898: Medical Devices; Hematology and Pathology Devices; Classification of the Von Willebrand Factor Assay

Federal Register, Volume 91 Issue 104 (Monday, June 1, 2026) [Federal Register Volume 91, Number 104 (Monday, June 1, 2026)] [Rules and Regulations] [Pages 32336-32338] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2026-10898] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 864 [Docket No. FDA-2026-N-5725] Medical Devices; Hematology and Pathology Devices; Classification of the Von Willebrand Factor Assay

Agency

Food and Drug Administration, HHS.

Action

Final amendment; final order. -----------------------------------------------------------------------

Summary

The Food and Drug Administration (FDA) is classifying the von Willebrand factor assay into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the von Willebrand factor assay. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Dates

This order is effective June 1, 2026. The classification was applicable on September 29, 2022.

For Further Information Contact

Yan Cai, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3453, Silver Spring, MD 20993-0002, 240-402-1094, [email protected].

Supplementary Information

I. Background

Upon request, FDA (the Agency or we) has classified the von Willebrand factor (VWF) assay into class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness of the device. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment. The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified into, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (21 U.S.C. 360c(f)(1)). We refer to these devices as ``postamendments devices'' because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807). FDA may also classify a device through ``De Novo'' classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)). Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo classification process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification. [[Page 32337]] Under the first procedure, the person submits a premarket notification (510(k)) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act. Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device. We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C Act). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see section 513(i) of the FD&C Act, defining ``substantial equivalence''). Instead, sponsors can use the less burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

On October 28, 2020, FDA received Siemens Healthcare Diagnostics Products GmbH's request for De Novo classification of the INNOVANCE VWF Ac device. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness of the device, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see section 513(a)(1)(B) of the FD&C Act). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on September 29, 2022, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 864.7293.\1\ We have named the generic type of device ``von Willebrand factor assay,'' and it is identified as a prescription device intended for the measurement of von Willebrand factor activity or von Willebrand factor size distribution in human plasma. This device is indicated to aid in the diagnosis and management of patients being evaluated for von Willebrand factor disorders in conjunction with other clinical and laboratory findings. --------------------------------------------------------------------------- \1\ FDA notes that the ``ACTION'' caption for this final order is styled as ``Final amendment; final order,'' rather than ``Final order.'' Beginning in December 2019, this editorial change was made to indicate that the document ``amends'' the Code of Federal Regulations. The change was made in accordance with the Office of Federal Register's (OFR) interpretations of the Federal Register Act (44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and parts 21 and 22), and the Document Drafting Handbook. --------------------------------------------------------------------------- FDA has identified the risks to health associated with this type of device and the measures required to mitigate these risks in table 1. Table 1--Risks to Health and Mitigation Measures for Von Willebrand Factor Assays ------------------------------------------------------------------------ Identified risks to health Mitigation measures ------------------------------------------------------------------------ Falsely elevated VWF activity results Certain design verification and may lead to delayed diagnosis and validation identified in delayed patient management of von special control (1), including Willebrand disease (VWD). Patients documentation of certain with delayed diagnosis and resulting analytical studies and delayed patient management of VWD are clinical studies. at increased risk of bleeding due to Certain labeling information the withholding of appropriate identified in special control treatment. (2), including limitations and performance information identified in special control (1). Falsely depressed VWF activity results Certain design verification and may lead the physician to suspect VWD validation identified in in patients who do not have the special control (1), including disease. As a result, the patients may documentation of certain receive unnecessary follow-up testing analytical studies and and unnecessary treatment as well as clinical studies. delays in receiving a correct Certain labeling information diagnosis and appropriate patient identified in special control management. In addition, affected (2), including limitations and patients may experience mental anxiety performance information because of the erroneous diagnosis. identified in special control (1). No results may lead to delayed patient Certain design verification and management. validation identified in special control (1), including documentation of certain analytical studies and clinical studies. Certain labeling information identified in special control (2), including limitations and performance information identified in special control (1). ------------------------------------------------------------------------ FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness of the device. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this final order. At the time of classification, von Willebrand factor assays are for prescription use only. Therefore, these devices are subject to the prescription labeling requirements for in vitro diagnostic (IVD) products (see 21 CFR 809.10(a)(4) and (b)(5)(ii)). Under the FD&C Act, submission of a premarket notification under section 510(k) is required to reasonably assure the safety and effectiveness of class II devices unless FDA determines that the [[Page 32338]] device type should be exempt under section 510(m) of the FD&C Act. At this time FDA has not made this determination for von Willebrand factor assays. This device is therefore subject to premarket notification requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not normally have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These 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 part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval have been approved under OMB control number 0910- 0231; the collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820 regarding quality management system regulation have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR parts 801 and 809 regarding labeling have been approved under OMB control number 0910-0485. List of Subjects in 21 CFR Part 864 Blood, Medical devices, Packaging and containers. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 864 is amended as follows: PART 864--HEMATOLOGY AND PATHOLOGY DEVICES 0