Manufacturers with documented compliance problems may benefit from interventions modeled on the US Food and Drug Administration’s Voluntary Improvement Program (VIP), a recent report from the Medical Device Innovation Consortium (MDIC) states.
MDIC’s ASC Pilot Shows Continuous Improvement Approach May Work For More Manufacturers
A recent pilot program from public-private partnership MDIC attempted to apply the FDA’s established Voluntary Improvement Program framework to manufacturers with known compliance issues. Participants found an improved mindset, a better relationship with the FDA, and conclusions to ongoing enforcement actions.
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