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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Applicability of the Alternative Standards

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900.18(f)(1)(2)(3): Applicability of the alternative standards.

(1) Except as provided in paragraphs (f)(2) and (f)(3) of this section, any approval of an alternative standard, amendment, or extension may be implemented only by the entity to which it was granted and under the terms under which it was granted. Other entities interested in similar or identical approvals must file their own application following the procedures of paragraph (c) of this section.

(2) When an alternative standard is approved for a manufacture of equipment, any facility using that equipment will also be covered by the alternative standard.

(3) The agency may extend the alternative standard to other entities when FDA determines that expansion of the approval of the alternative standard would be an effective means of promoting the acceptance of measures to improve the quality of mammography. All such determinations will be publicized by appropriate means.