FDA Moves Blood Test Device Into Class II
Published Date: 6/1/2026
Rule
Summary
The FDA is officially putting the von Willebrand factor assay into Class II, meaning it now has special safety rules but fewer red tape hurdles. This change helps labs and patients get access to this important blood test faster and safer, starting June 1, 2026. If you make or use these devices, expect smoother approvals and no big cost jumps.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Easier Approval Path for Test Makers
The FDA officially classified the von Willebrand factor assay as Class II with special controls effective June 1, 2026 (classification applicable September 29, 2022). That classification lets this device serve as a predicate for future devices so sponsors can use the less burdensome 510(k) premarket notification process instead of a De Novo request or premarket approval.
Faster, Safer Patient Access to Test
FDA says classifying the von Willebrand factor assay into Class II will provide a reasonable assurance of safety and effectiveness and will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens; the order is effective June 1, 2026 (classification applicable September 29, 2022). The device is a prescription test intended to aid diagnosis and management of von Willebrand factor disorders.
New Test Makers Must Meet Specific Study and Label Rules
Manufacturers marketing a von Willebrand factor assay must meet special controls that include detailed design verification and validation (analytical performance such as precision, linearity, detection capability, specimen/reagent stability, and hook effect), clinical comparison studies using representative clinical samples conducted at a minimum of three external sites, pediatric validation when applicable, and labeling that identifies known interferents and summarizes performance. The device remains prescription-only and is subject to premarket notification under section 510(k).
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-17659, Rahim Shafa; Denial of Hearing; Final Debarment Order
The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Rahim Shafa (Dr. Shafa) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Dr. Shafa from providing services in any capacity to a person that has an approved or pending drug product application and debarring Dr. Shafa for 20 years from importing or offering for import any drug into the United States. FDA bases this order on the findings that Dr. Shafa was convicted of multiple felonies under Federal law that relate to the regulation of any drug product under the FD&C Act and the importation into the United States of any drug or controlled substance under the FD&C Act. FDA provided notice to Dr. Shafa of the proposed debarment and an opportunity to request a hearing. Dr. Shafa submitted a request for a hearing but failed to file with the Agency information and analyses sufficient to create a basis for a hearing.
2026-17676, Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated Fees
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection pertaining to the registration of human drug compounding outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and associated fees.
2026-17598, Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups and Interviews as Used by the Food and Drug Administration
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the generic collection of focus group information as used by FDA for all FDA-regulated products.
Previous / Next Documents
Previous: 2026-10896, Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments
Starting June 1, 2026, the FAA is updating how pilots approach and take off from certain airports to keep flights safe and smooth. These changes include new rules for landing and takeoff paths because of new tech, obstacles, or air traffic needs. Pilots and airports affected should check the updated procedures online—no extra costs, just safer skies!
Next: 2026-10899, Medical Devices; Dental Devices; Classification of the Intraoral Cooling Device
The FDA is officially putting the intraoral cooling device into class II, meaning it has special safety rules but fewer hurdles than the highest-risk devices. This change helps make sure the device is safe and effective while making it easier for patients to get this cool tech. The new classification is effective June 1, 2026, but it’s been in place since October 14, 2022, so manufacturers can plan ahead without extra costs.