The AAMI contract approach to standards development.

Abstract

In summary, the AAMI approach enables the FDA to utilize all available resources needed to identify critical characteristics that should be subjected to standards; to develop rationale for those parameters that should not be subjected to standards; and to develop standards in those areas where standards should be developed. During the process, appropriate checks and balances are available because of AAMI's multidisciplinary approach, which is not available using other approaches. The AAMI approach is extremely participatory and, consequently, will result in the production of a standard that will be acceptable to the largest number of people without compromising critical safety and efficacy considerations.