FDA finalizes exemption for certain class II clinical toxicology test systems
The FDA issued a final order exempting specific class II clinical toxicology test systems from premarket notification (510(k)) requirements, effective October 6, 2026. 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.
Primary source
Federal Register rule, October 6, 2026
Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems
Read the source: Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems federalregister.gov
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