Applications for Approval of an Alternative Standard
900.18(c)(1)(2)(3)(4)(5)(6): An application for approval of an alternative standard or for an amendment or extension of the alternative standard shall be submitted in an original and two copies to the Director, Division of Mammography Quality and Radiation Programs (HFZ-240), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. The application for approval of an alternative standard shall include the following information:
(1) Identification of the original standard for which the alternative standard is being proposed and an explanation of why the applicant is proposing the alternative;
(2) A description of the manner in which the alternative is proposed to deviate from the original standard;
(3) A description, supported by data, of the advantages to be derived from such deviation;
(4) An explanation, supported by data, of how such a deviation would ensure equal or greater quality of production, processing, or interpretation of mammograms than the original standard;
(5) The suggested period of time that the proposed alternative standard would be in effect; and
(6) Such other information required by the Director to evaluate and act on the application.