No, personal breathalyzers do not require FDA approval (or clearance) before being sold in the United States. The FDA classifies personal breathalyzers as Class I medical devices, which means they are low-risk and subject to general regulations. Most Class I devices, including breathalyzers, are exempt from the FDA’s premarket approval process (also known as 510(k) clearance). This means that manufacturers do not need to submit their product for FDA approval before selling it.
Even though FDA approval is not required, manufacturers must still:
✔️ Register with the FDA and list their products in the FDA database
✔️ Follow good manufacturing practices to ensure quality and accuracy
✔️ Label the product properly, with no false or misleading claims
✔️ Report any safety issues related to the device
Did Personal Breathalyzers Ever Require FDA Approval?
Yes. Before 2019, the FDA required breathalyzers to go through its 510(k) clearance process, which meant manufacturers had to prove that their device was as safe and effective as an already-approved model.
Some BACtrack breathalyzers that previously received FDA 510(k) clearance include:
However, in December 2019, the FDA reclassified breathalyzers as Class I medical devices that are exempt from the 510(k) clearance process. Since then, personal breathalyzers no longer require FDA approval before being sold.
Further Reading
For more details on FDA regulations and breathalyzer approvals, check out the following sources:
FDA Regulations & Government Standards
-
FDA Classification of Breathalyzers – Explains why personal breathalyzers are Class I medical devices and exempt from 510(k) approval since 2019.
-
FDA Device Registration & Listing – Ensures breathalyzer manufacturers are registered with the FDA.
-
DOT/NHTSA Approved Breathalyzers – List of breathalyzers that meet Department of Transportation (DOT) standards.
BACtrack FDA Clearances (Before 2019 Exemption)
-
✅ BACtrack S80 FDA 510(k) Clearance – Previously required approval before the 2019 rule change.