Criteria for Approval of Alternative Standards
900.18(a)(1)(2)(3): Upon application by a qualified party as defined in paragraph (b) of this section, FDA may approve an alternative to a quality standard under section 900.12, when the agency determines that:
(1) The proposed alternative standard will be at least as effective in assuring quality mammography as the standard it proposes to replace; and
(2) The proposed alternative:
(i) Is too limited in its applicability to justify an amendment to the standard; or
(ii) Offers an expected benefit to human health that is so great that the time required for amending the standard would present an unjustifiable risk to the human health; and
(3) The granting of the alternative is in keeping with the purpose of 42 U.S.C. 263b.