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FDA Report: MDSAP Single-Audit Pilot Challenged By Device-Maker Recruitment

This article was originally published in Clinica

Executive Summary

Although international regulators are seeking 330 manufacturers to participate in the three-year Medical Device Single Audit Program pilot by the end of 2016, they have recruited only 45 as of the 18-month midway point, according to an MDSAP Mid-Pilot Status Report released on Sept. 10 by the FDA.

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