Important Notice -- All requests for exempt tests/methods must be received by the Board office no later than June 1, 2012
in order for them to be considered for addition to the Administrative Rules in Fall 2012. If the FDA pulls approval on any of the exempt tests/methods, it is the responsibility of the lab that is using this test/method to follow the FDA requirements for further testing.
To request an exemption of a test/method from N.D.C.C. 43-48-03, you must explain the instrumentation of each test and also must include package inserts.
The Board uses three criteria in determining if a test should be exempt:
(1) Methodology/Instrumentation must be included in List of Tests Waived by FDA. If the test is not on this list, it will not be approved for exemption.
(2) Exemption should improve patient care as well as provide additional staffing options.
(3) Exemption should have a positive outcome on patient consequences. please complete and submit the
Request for Exemption of Test/Method From Current Licensure form.