USA – FDA drafts guidance on medical device voluntary improvement program

The US Food and Drug Administration (FDA) has issued draft guidance describing the agency’s participation in a permanent medical device Voluntary Improvement Program (VIP) that uses third-party appraisals to evaluate manufacturing practices.

The VIP is operated by the Medical Device Innovation Consortium (MDIC) and builds on the experience of the Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program.

As in the pilot program, VIP oversees third-party appraisers who evaluate industry participants using best practices in the Information Systems Audit and Control Association (ISACA) Capability Maturity Model Integration (CMMI) system. VIP uses a version of the CMMI appraisal that is appropriate for the medical device industry, covering 11 practice areas including estimating, planning, and configuration management…