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US to be canvassed on whether FDA performance criteria are "appropriate"

This article was originally published in Clinica

Executive Summary

The US FDA's device centre has scheduled a stakeholder meeting for May 22 to solicit public comment on whether it should revise two user-fee-related performance goals for fiscal year 2007. The two performance goals are considered to be the most ambitious commitments made by the FDA in 2002, when it was trying to win industry's support for device user fees. One pledges that the device review staff would complete work on 50% of the premarket approval applications or PMAs within 180 days. The other calls for processing 80% of all 510(k)s within 90 days.

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