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:
- What process is FDA currently following to arrive at a decision on a request for approval of an alternative requirement?
- How long does this process take?