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PMA (premarket approval) review times continue to fall in the US

This article was originally published in Clinica

Executive Summary

The FDA has reduced further the time it takes to process applications to market medical devices in the US. In fiscal year 1998, which ended on September 31, the average review time for premarket approval applications (PMAs) from submission to approval fell to 12.4 months, a substantial 25% reduction on the 16.6 month average in 1997 and 50% less than the average of 25.9 months in 1996.

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