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Clear allHow Does FDA Categorize Tests under CLIA?
FDA assigns CLIA categories of waived, moderate or high complexity by scoring a test from 1 to 3 on seven criteria. A total of 12 or less is moderate, and above 12 is high.
Read moreWhat Did FDA's October 2026 Order Change for Drug Test Devices?
Effective October 6, 2026, FDA exempted certain class II drug test systems for federal drug testing programs from 510(k) premarket notification if used for employment and insurance testing.
Read moreHow Does FDA Classify Drug Test Devices?
Most drug of abuse test systems are class II devices under 21 CFR Part 862, exempt from 510(k) only for employment or insurance testing. Breath alcohol test systems are class I.
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