Radiation-Emitting Products

Alternative Requirements Overview

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900.18 (a) Criteria for approval of alternative standards.

Upon application by a qualified party as defined in paragraph (b) of this section, FDA may approve an alternative to a quality standard under Sec. 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 purposes of 42 U.S.C. 263b.
  1. What process is FDA currently following to arrive at a decision on a request for approval of an alternative requirement?
  2. How long does this process take?


Page Last Updated: 09/29/2014
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