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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Amendment or Extension of an Alternative Standard

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Citation:

900.18(e)(1)(2)(3): An application for amending or extending approval of an alternative standard shall include the following information:

(1) The approval number and the expiration date of the alternative standard;

(2) The amendment or extension requested and the basis for the amendment or extension; and

(3) An explanation, supported by data, of how such an amendment or extension would ensure equal or greater quality of production, processing, or interpretation of mammograms than the original standard.