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

A mid-pilot program update from the Medical Device Single Audit Program shows the number of interested manufacturers spiked sharply in July, but is still a far cry from the end-of-2016 target of 330 participating companies. However, the pilot is meeting auditor recruitment and training goals.

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

released Sept. 10 by FDA.

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