Compliance 360° Part 7: Factors Feeding Your Inspection Cycle – A New Paradigm
• By Shawn M. Schmitt
This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this seventh installment, former FDA investigations branch director Ricki Chase explains how new initiatives within the agency and center for devices – including FDA's in-the-works "program alignment" inspection initiative, may affect your facility audits. Also discussed: the Medical Device Single Audit Program (MDSAP), the joint FDA/Medical Device Innovation Consortium (MDIC) Case for Quality, and FDA's Voluntary Compliance Improvement Program (VCIP).
Device-makers that manufacture high-risk products or have risky manufacturing operations will likely be inspected more often under US FDA's in-the-works "program alignment" inspection initiative, a former FDA investigations branch director says.
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