Tag: 510_k_clearance

FDA Seeks Public Comment on Removing 510(k) Clearance for Federal Drug Testing

9 Jun 2026 9:31 a.m. · Source: DOT - Office of Drug & Alcohol Policy & Compliance

The FDA proposes removing the 510(k) clearance requirement for federal drug testing programs, including DOT's. This change impacts laboratories and testing providers. The DOT urges stakeholders to review the proposal and submit comments by June 30, 2026.

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