Criteria for Approval of Alternative Standards

Citation:

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.