FDA Pushes Medical Device Self-Audit Pilot Program

Law360, New York (December 12, 2013, 9:05 PM EST) -- The U.S. Food and Drug Administration asked medical device manufacturers on Wednesday to consider joining a pilot program that allows them to self-audit for quality system violations and other issues that do not raise imminent public health concerns.

Instead of undergoing routine FDA surveillance inspections, companies in the Voluntary Compliance Improvement Program would be expected to self-identify and fix failures to meet device clearance or approval requirements, adverse event reporting requirements or similar issues, according to the agency.

The companies would have to hire an outside...
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