NFW · Class II · 21 CFR 862.3870

FDA Product Code NFW: Test, Cannabinoid, Over The Counter

Leading manufacturers include Healgen Scientific, LLC.

4
Total
4
Cleared
75d
Avg days
2019
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg 185d recently vs 39d historically

FDA 510(k) Cleared Test, Cannabinoid, Over The Counter Devices (Product Code NFW)

4 devices
1–4 of 4

About Product Code NFW - Regulatory Context

510(k) Submission Activity

4 total 510(k) submissions under product code NFW since 2019, with 4 receiving FDA clearance (average review time: 75 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA Review Time

Recent submissions under NFW have taken an average of 185 days to reach a decision - up from 39 days historically. Manufacturers should account for longer review timelines in current project planning.

NFW devices are reviewed by the Toxicology panel. Browse all Toxicology devices →