Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is publishing an order setting forth its final determination to exempt certain class II clinical toxicology test systems from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k) requirements, subject to certain limitations, is immediately in effect for such devices. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is amending the classification language within the Code of Federal Regulations (CFR) for certain class II clinical toxicology test systems to reflect this final determination. FDA is publishing this order in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Part 862 [Docket No. FDA-2026-N-4268] AGENCY: Food and Drug Administration, HHS. ACTION: Final amendment; final order. SUMMARY: The Food and Drug Administration (FDA) is publishing an order setting forth its final determination to exempt certain class II clinical toxicology test systems from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k) requirements, subject to certain limitations, is immediately in effect for such devices. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is amending the classification language within the Code of Federal Regulations (CFR) for certain class II clinical toxicology test systems to reflect this final determination. FDA is publishing this order in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). DATES: This order is effective October 6, 2026. FOR FURTHER INFORMATION CONTACT: Joseph Kotarek, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3528, Silver Spring, MD 20993, 301-796-2718, Joseph.Kotarek@fda.hhs.gov . SUPPLEMENTARY INFORMATION: I. Background Under section 510(k) of the FD&C Act ( 21 U.S.C. 360(k) ) and FDA's implementing regulations in part 807, subpart E of the CFR ( 21 CFR part…
Other Federal Register documents from the same docket.
Citation: 91 FR 63478
