Device approval procedure

Device approval procedure. (1) Approval requirement. (a) No device may be leased, sold, serviced, repaired, installed or used unless the model and any system firmware or software used on the device have been approved by the department in accordance with the requirements of this chapter. Approval may be granted by testing the functionality of the device with the proposed changes. (b) Device approval is personal to an applicant and cannot be assigned or transferred. Upon sale of production rights to a device, change in ownership of a manufacturer or vendor, or other change resulting in a new person seeking to distribute devices in this state, the new person must apply for device approval. The department may waive some or all of the testing of the device portion of the approval process if the new applicant is able to demonstrate that no substantive changes to the device have been made since the prior approval. (2) Application. (a) An applicant may apply for approval of a device by submitting a written application to the department in the manner prescribed in this chapter on the department’s form, and shall certify that the device: 1. Does not impede the safe operation of a vehicle; 2. Minimizes opportunities to bypass the device; 3. Performs accurately and reliably under all circumstances; 4. Minimizes inconvenience to customers and other vehicle operators; 5. Satisfies the requirements for certification set forth in this section, and; 6. Prevents a customer from starting a vehicle when the customer has a prohibited alcohol concentration. (b) The applicant shall include all of the following information in an application for device approval: 1. The name and address of the manufacturer of the device. 2. The name and model number of the device. A separate application is required for each model or type of device. 3. A detailed description of the device including complete instructions for installation, operation, service, repair and removal, including all documents used as training materials or manuals for installation, maintenance or removal of the device at service centers. 4. Complete description of device functionality including technical specifications describing the device’s accuracy, reliability, security, data collection and recording, tamper detection, alert mode and environmental features. 5. A complete and accurate copy of an independent laboratory report issued to the applicant substantiating that the device meets or exceeds the minimum federal standards adopted in sub. (5) . The report shall be submitted with a notarized certification from the independent laboratory and shall include copies of the laboratory’s certificates of accreditation. 6. A description of the applicant’s present or planned provisions for distribution and service of the device in Wisconsin. The applicant shall, within 6 months of receipt by the department of an application for approval of a device, provide the chemical testing section with a list of all locations in Wisconsin where the device may be purchased, installed, removed, serviced, repaired, calibrated, inspected and monitored. 7. A certificate from an insurance company licensed in Wisconsin evidencing that the manufacturer holds product liability insurance as required in s. Trans 313.05 . 8. Indication of whether the manufacturer or manufacturer-approved authorized device repair facility, or both, will repair handsets and vehicle modules. If any device repair facilities are not directly operated by the manufacturer, the qualification and background requirements for repair technicians at those facilities must also be submitted to the department. 9. Copies of all contracts, lease agreements, and other form documents used by the service providers to enter into a contractual relationship with a customer. 10. A list of other jurisdictions in which the applicant applied for approval of the device in that jurisdiction and a statement as to whether the application was approved, denied, withdrawn, remains pending, or was subject to some other disposition. If the application was denied, withdrawn, or subject to some other disposition, the applicant shall provide an explanation for that action on the application and copies of all documents from that jurisdiction documenting the decision in that jurisdiction and the reasons for that decision. 11. A release authorizing any other jurisdiction to share with the department any and all tests or evaluations of the device, data derived therefrom, and all materials provided to the other jurisdiction in support of that other application. 12. A certificate of authority or registration, obtained from the Wisconsin Department of Financial Institutions, in accordance with s. 180.1501 or 183.1004 , Stats., or a copy of the articles of incorporation for any cooperative filed in accordance with s. 185.82 , Stats., for all manufacturers, vendors and service providers anticipating to lease, sell, service, repair, install or uninstall the device in Wisconsin. 13. All relevant manufacturer, vendor and service provider documents relating to the quality assurance of the calibration procedure and device verification checks. 14. An affirmation, on the department’s form, of all the following: a. That the applicant will provide, at the written request of the state, or any prosecutor in this state, testimony that is sought in any civil or criminal proceeding or administrative hearing regarding the device, its manufacture, use, or function, its installation, repair or removal, interpretation of any recorded report or information from or about the device, or the performance of any duties required under this chapter, without cost to the state, county, municipality, town, police agency, or prosecutor. b. That the manufacturer will provide statewide service for the device in accordance with s. Trans 313.09 (1) . 15. Contact information for its registered agent for service of process in this state. The applicant shall notify the department if its registered agent changes. 16. The minimum qualifications for a manufacturer-approved authorized service center and training materials provided to or used by manufacturer-approved authorized service centers. 17. If the device has previously been evaluated by the department, an explanation of all modifications made to the hardware and software of the device since that evaluation, a data supported explanation as to why the applicant believes that the modifications made to the device should result in the successful evaluation of the device, and any test results for the device the applicant has performed. 18. A document that clearly describes the manufacturer’s or vendor’s quality control process for resolving noncompliance with the requirements of this chapter by its service providers. 19. An explanation of responsibility for responding to consumer questions and complaints, as required by s. Trans 313.10 (2) (c) . 20. Any other information required on the department’s form. (c) An applicant shall respond to all the department’s inquiries into any deficiency of the applicant’s application in a timely manner. If an applicant fails to respond to and remedy any application deficiency brought to its attention by the department within 90 days, the application is considered incomplete and the applicant shall restart the application process. (3) Time for decision. The department shall approve or disapprove a device not later than 30 days after receipt of all required application materials and completion of all equipment testing. (3m) Evaluation queue. (a) Once the department receives an application with all the information required in sub. (2) , the department shall place that application in an evaluation queue maintained by the department. (b) The department shall evaluate devices in the order its corresponding application is placed in the evaluation queue, except as provided in par. (d) . (c) The department shall notify an applicant at the time its device reaches the point in the evaluation queue that the department is prepared to begin testing the device. (d) The department may require installation of devices under sub. (4) (b) by a prescribed deadline. Failure to install devices by that deadline may result in the device evaluation being delayed. If an applicant fails to install devices by any required deadline, the department may provide notice to the next applicant in the evaluation queue and evaluate that other device. (4) Evaluation. (a) The applicant shall submit at least two devices, as specified in the application, to the department for evaluation. The department may require different functions or features to be activated for the two devices. (b) The applicant, or its agent on its behalf, shall install the device in a vehicle provided by the department. When applicable, the applicant shall provide the department with an adequate supply of disposable mouthpieces. (c) The department shall independently evaluate each device to ensure compliance with the requirements in sub. (5) . The evaluation criteria include, but are not limited to, repeated testing of alcohol-laden samples, filtered samples, circumvention attempts and tampering. (d) During the evaluation period, the applicant shall provide the department with a computer that has all software for the department to access test data from the device in near real-time or no later than 24 hours after a test is performed, or some other mechanism that provides that functionality. (e) If the department disapproves a device based on a failed evaluation, an application for the device may not be evaluated, nor placed in the evaluation queue under sub. (3m) (a) , nor may the device be evaluated for 6 months. The department may waive this required 6-month period if the application is accompanied by all application materials specified in sub. (2) (b) 17. (5) Standards and specifications. An applicant shall ensure that any device that it distributes for use in the state of Wisconsin meets all the following requirements: (a) Minimum federal standards for devices. All devices shall meet or exceed the standards established by the U.S. department of transportation, national highway traffic safety administration, identified as “Model Specifications for Breath Alcohol Ignition Interlock Devices (BAIID)” 78 Fed. Reg. 89, pp. 26849–26867 (May 8, 2013). (b) Retest feature. The device shall be programmed to have a retest feature. The retest feature shall require the driver to submit to a sample sequence no more than 5 minutes after the vehicle is made operable following a successful start sequence. The retest feature shall require additional subsequent tests at random intervals of 5 to 30 minutes until the vehicle ceases operation. (bm) Failed retests. The device’s retest feature shall be programmed to include all of the following features: 1. ‘Activation of Alert.’ A driver’s failure to provide a breath sample that is less than the device’s alcohol setpoint shall trigger a confirmation retest sequence, as described in subd. 2. If the driver does not provide a passing breath sample in response to the confirmation retest, the device shall activate the device’s alert mode until the earlier of the time the vehicle is shut off, or the time the driver provides a passing breath sample to the device. 2. ‘Confirmation retest.’ Upon activation of a confirmation retest sequence under subd. 1. , a device shall wait 2 minutes and then commence a sample sequence. If no passing sample is provided as part of the sample sequence, the device shall activate its alert mode. Upon expiration of the sample sequence, the device shall resume normal retest intervals.