FDA Moves to Expand 510(k) Exemptions for Certain Class II Devices, Including Clinical Toxicology Test Systems

The U.S. Food and Drug Administration published a notice in the Federal Register on May 1, 2026, announcing its intent to expand 510(k) exemptions for Class II devices within the clinical toxicology test system category. The notice opens a 60-day public comment period, with comments due by June 30, 2026, and marks the latest action in a continuing FDA effort to streamline premarket requirements for lower-risk device types under authority granted by the 21st Century Cures Act of 2016. 

The FDA is announcing its intent to exempt from premarket notification requirements certain Class II clinical toxicology test system devices, while noting that the notice does not represent its final determination. Manufacturers and industry stakeholders have until June 30, 2026, to submit comments via the federal rulemaking portal before the agency proceeds toward a final order. Federal Register 

What the 21st Century Cures Act Requires 

The procedural framework behind this notice traces back to Section 510(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as reinforced by the 21st Century Cures Act. Under Section 510(m)(2), the FDA may exempt a Class II device from the premarket notification requirement upon its own initiative or following a petition from an interested party, if the agency determines that a 510(k) submission is not necessary to assure the safety and effectiveness of the device. The FDA must publish a notice of this intent and provide a 60-calendar-day period for public comment. Federal Register 

Within 120 days of issuing a notice, the FDA must publish an order in the Federal Register with its final determination. That timeline matters for manufacturers tracking when a potential exemption would actually take effect. Federal Register 

The Devices in Scope 

The May 2026 notice focuses specifically on Class II clinical toxicology test system devices, which are used to detect and measure drugs, metabolites, and other toxic substances in biological specimens. These devices are commonly used in clinical laboratories, workplace drug testing programmes, and point-of-care settings. 

Before finalising any exemption, the FDA will review public comments and consider whether the proposed exemption should be modified. The agency applies several factors when evaluating whether a device qualifies, including whether the device has a history of false or misleading claims, whether its safety and effectiveness characteristics are well established, and whether changes to the device could affect patient safety in ways that would not be readily detectable. Federal Register 

Critically, exemptions from premarket notification do not mean blanket deregulation. Exempted devices remain subject to other regulatory requirements, including good manufacturing practice obligations and applicable special controls. I3CGlobal 

A Pattern of Incremental Regulatory Relief 

The May 2026 notice follows a consistent pattern of action. Earlier in 2026, the FDA published a separate notice identifying a list of Class II devices it proposed to exempt from premarket notification requirements, subject to certain limitations, with comments due by April 7, 2026. That February 2026 notice covered a broader range of device types across multiple product codes. Federal Register 

FDA’s deregulatory actions in this space operate under authority gained through the 21st Century Cures Act of 2016, which requires the FDA to identify low-risk devices that it determines no longer require a 510(k) review to provide reasonable assurance of safety and effectiveness. The cumulative effect of these actions is a gradual reshaping of which device categories require premarket clearance and which do not. MedTech Dive 

A recent example of a completed cycle: the FDA finalised an exemption for certain Class II clinical electronic thermometers in June 2025, following the same notice-and-comment process, with the order taking immediate effect. That precedent illustrates how the current May 2026 proposal could move through to a final order before the end of the calendar year. Federal Register 

What This Means for Your Business 

For medical device manufacturers, this proposal carries practical implications regardless of whether your specific product codes are on the current list. 

First, companies in the clinical toxicology space should review the Federal Register notice directly to determine whether their device type falls within scope. An exemption, if finalised, would remove the obligation to submit a 510(k) for covered device types, potentially shortening time-to-market and reducing the administrative burden associated with premarket clearance. That said, the change does not eliminate the need for regulatory rigour. Design controls, quality system requirements under 21 CFR Part 820, and applicable special controls would continue to apply. 

Second, the comment period represents a genuine opportunity to engage. If your organisation believes a proposed exemption is too broad, too narrow, or would create unintended consequences for your product line, the public comment process is the mechanism to raise those concerns before the final order is published. The deadline is June 30, 2026. 

Third, manufacturers operating outside the clinical toxicology space should not treat this notice as irrelevant. The FDA’s expanding use of Section 510(m) signals a continuing commitment to regulatory reform for lower-risk Class II devices more broadly. Companies with products across multiple device categories should monitor these notices as part of their standard regulatory intelligence practice.