Report on Additional MDUFA II Performance Commitments
Under MDUFA II, FDA made several commitments related to the medical device review process in addition to performance goals. These commitments include maintaining performance in areas not covered by explicit performance goals, applying the interactive review program, and using informal and formal meetings to advance reviews. Other performance commitments include quarterly reports on performance, continued focus on reviewer training, and development of guidance documents. Additional information on these commitments is presented in section I, paragraphs G through P, of FDA’s Commitment Letter in Appendix A.
Measuring performance: MDUFA II commitments are presented using quantitative measures (standard statistics) and descriptive measures, where applicable, to assess performance. For descriptive measures, progress is reported through narrative accounts outlining specific actions taken, in addition to any results attributed to those actions. For example, FDA’s implementation of an interactive review program can be described, but not quantified.
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