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www.fdanews.com/articles/168795-devicemakers-wont-see-warning-letters-under-single-audit-pilot

Devicemakers Won’t See Warning Letters Under Single-Audit Pilot

November 28, 2014

International medical device regulators are trying to entice more companies to participate in a single-audit pilot program, promising they will receive no warning letters unless there is an immediate threat to public health.
International Medical Device Regulatory Monitor