FDA product code · Clinical toxicology

Test, Methamphetamine, Employment And Insurance Testing, Exempt

Name: FDA decisions, review times, recalls and adverse event reports for product code PVD
Creator: 510(k) Report

PVDClass II21 CFR 862.3610510(k) exempt0 decisions0 recalls

FDA lists PVD as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 862.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. No recall names this code.

The methamphetamine test is an in vitro diagnostic test for the qualitative analysis of methamphetamines for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, clinical toxicology panel

Twenty years of PVD at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · PVD

FDA has decided no PVD device since 2007.

Median 510(k) review, days · PVD

Too few PVD 510(k)s in any year since 2007 to give a median.

Recalls per year · PVD

No recall names PVD since 2007.

Adverse event reports per year · PVD

1in 2022

2007high 1 (2018) · low 0 (2007)2025

MAUDE reports naming product code PVD, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	1
2019	—	0
2020	—	0
2021	—	1
2022	—	1
2023	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — PVD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PVD? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 862.3610.

NGG Test, Methamphetamine, Over The Counter DJC Thin Layer Chromatography, Methamphetamine LAG High Pressure Liquid Chromatography…LAF Gas Chromatography, Methamphetamine