Comment from Julie Herron

Comment on FDA Docket No. FDA-2026-N-4268 Medical Devices; Exemptions from Premarket Notification: Certain Class II Devices; Request for Comments To Whom It May Concern: I support FDA’s proposal to remove the current limitation that excludes devices intended for Federal drug testing programs from the existing 510(k) exemption for the identified class II clinical toxicology test systems. From an employer and public-sector operations perspective, this change is appropriate and warranted. Federal drug testing programs already operate within highly controlled testing frameworks that include defined specimen collection procedures, chain-of-custody requirements, laboratory standards, cutoff levels, confirmatory testing protocols, medical review processes, and oversight requirements. In that context, requiring a separate 510(k) submission for otherwise exempt class II toxicology devices intended for Federal drug testing programs adds regulatory burden without a commensurate increase in safety or effectiveness. FDA’s notice correctly explains that these device types already have well-established characteristics, are subject to general and special controls, and can remain subject to the general limitations of exemption under 21 CFR 862.9. Those controls provide an appropriate regulatory backstop. Retaining the exemption limitations solely because a device is intended for a Federal drug testing program appears unnecessary where the same device technology is already considered sufficiently understood and controllable for employment and insurance testing. Removing this limitation would produce several practical benefits: 1. Improve access to compliant testing tools. Public and private employers that must administer drug testing under Federal requirements benefit when manufacturers have a clearer and less burdensome pathway to market for eligible test systems. 2. Reduce unnecessary regulatory costs. Eliminating duplicative premarket notification requirements for devices that FDA has determined no longer need 510(k) review will reduce costs for manufacturers and may help stabilize supply and pricing for end users. 3. Support program continuity and operational efficiency. Organizations subject to Federal testing requirements, including transit employers and other safety-sensitive sectors, depend on predictable availability of testing products. Streamlining unnecessary premarket requirements can help reduce delays in product availability and updates. 4. Maintain appropriate safety protections. The proposed change does not remove FDA oversight altogether. These devices would still remain subject to applicable general controls, special controls, labeling requirements, and the limitations of exemption in 21 CFR 862.9. Devices that exceed those limitations would still require premarket review. I encourage FDA to finalize the proposed removal of the exclusion for devices intended for Federal drug testing programs across the device types listed in the notice, including amphetamine, barbiturate, benzodiazepine, cocaine and cocaine metabolite, codeine, LSD, methamphetamine, methadone, methaqualone, morphine, opiate, propoxyphene, cannabinoid, and tricyclic antidepressant test systems. Overall, the proposal is a sensible modernization that reduces burden while preserving the controls necessary to assure safety and effectiveness. I respectfully urge FDA to finalize the exemption expansion as proposed. Thank you, Julie Herron Employee Relations Administrator, DAPM/DER San Mateo County Transit District Millbrae, California