How Does a Manufacturer Get an Alcohol Screening Device on NHTSA's List?

A manufacturer applies to NHTSA for a test date, and the DOT Volpe National Transportation Systems Center (VNTSC) tests the device against NHTSA's Model Specifications for Screening Devices to Measure Alcohol in Bodily Fluids. The procedures described in NHTSA's March 31, 2008 Federal Register notice (73 FR 16956) state that tests are conducted semiannually, or as necessary.

Under those procedures, the manufacturer:

• Writes to the NHTSA Office of Behavioral Safety Research for a test date, and at least 30 days are typically required from the date of notification until the test can be scheduled
• Delivers the devices to VNTSC one week before the scheduled test program, at least 300 devices if they are disposable or a single device if they are reusable
• Delivers the operator's manual or instructions, any maintenance manual, and specifications and drawings fully describing the device and its use
• Self-certifies that it meets FDA Good Manufacturing Practices for medical devices (21 CFR Part 820, now titled the Quality Management System Regulation) and FDA labeling requirements (21 CFR 809.10), even if the devices are not to be used for medical purposes

The notice states that any malfunction resulting in failure to complete any of the tests satisfactorily results in a determination that the device does not conform, and that such a device may be resubmitted for the next testing cycle after appropriate corrections. If information shows that a device sold on the market does not meet the Model Specifications, the manufacturer has 30 days from notification to reply, and NHTSA then decides whether the device should remain on the CPL.

For DOT use, 49 CFR 40.235(a) requires the ASD manufacturer to submit a quality assurance plan (QAP) for NHTSA approval before NHTSA approves the device and ODAPC places it on its list of approved screening devices. The QAP rules are covered in What Quality Assurance Rules Apply to Alcohol Screening Devices?, and the list itself is covered in What Is NHTSA's Conforming Products List for Alcohol Screening Devices?.

Learn Laws® offers DOT Alcohol Screening Test Technician Training (STT), an online course for new STTs and refresher STTs under 49 CFR 40.213.

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