Radiation-Emitting Products

Alternative Standards (MQSA)

FDA may approve an alternative to a quality standard under section 900.12 when the agency determines that the proposed alternative standard will be at least as effective in assuring quality mammography as the standard it proposes to replace and is too limited in its applicability to justify an amendment to the standard or 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.

Alternative Standards

Page Last Updated: 09/26/2014
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