FDA product code · Clinical Toxicology · Class 2
NFT: Test, Amphetamine, Over The Counter
NFT is FDA's product code for "Test, Amphetamine, Over The Counter": a Class 2 device classified under 21 CFR 862.3100, reviewed by the Clinical Toxicology panel.
510(k) review time for NFT
Across 31 510(k) clearances under NFT decided from 2018-01-01 to 2026-10-06, the median was 40 days from FDA receipt to decision. Half took between 30 and 61 days, and 80% were decided within 65 days. These are past clearances, not a forecast for a new submission.
| Fastest | 21 |
|---|---|
| 25th percentile | 30 |
| Median | 40 |
| 75th percentile | 61 |
| 80th percentile | 65 |
| 90th percentile | 109 |
| Slowest | 243 |
| Year | Median days | n |
|---|---|---|
| 2018 | 56 | 6 |
| 2025 | 37 | 8 |
| 2026 (to 10-06, partial) | 35 | 5 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
NFT in the public FDA record
| Establishment listings | 154 |
|---|---|
| GUDID device identifiers | 2,146 |
Counts of records, not of devices or events. Adverse event reports for NFT are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite NFT
No FDA recognized consensus standard cites NFT by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.