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07/21/2022
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(a) As an ASD manufacturer, you must submit, for NHTSA approval, a QAP for your ASD before NHTSA approves it and ODAPC places the device on its Web page for “Approved Screening Devices to Measure Alcohol in Bodily Fluids”. Your QAP must specify the methods used for quality control checks, temperatures at which the ASD must be stored and used, the shelf life of the device, and environmental conditions (e.g., temperature, altitude, humidity) that may affect the ASD’s performance.
(b) As a manufacturer, you must include with each ASD instructions for its use and care consistent with the QAP. The instructions must include directions on the proper use of the ASD, and, where applicable the time within which the device must be read, and the manner in which the reading is made.
(c) As the user of the ASD (e.g., employer, STT), you must follow the QAP instructions.
(d) You are not permitted to use an ASD that does not pass the specified quality control checks or that has passed its expiration date.
(e) As an employer, with respect to breath ASDs, you must also follow the device use and care requirements of §40.233.
[82 FR 52246, Nov. 13, 2017]
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