Study: FDA-related activities cost $24 million per 510(k)

November 18, 2010 by MassDevice staff

Costs related to winning 510(k) clearance for a medical device that were directly related to satisfying Food & Drug Administration rules average $24 million, according to a Stanford University report.

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More than three-quarters of the cost to bring a medical device from concept to the U.S. market is spent clearing regulatory hurdles, according to a Stanford University report.

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