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Voluntary Improvement Program (VIP) for Medical Device Manufacturers: Participation Requirements and Implementation

This guidance describes FDA's policy regarding participation in the Voluntary Improvement Program (VIP), a voluntary program facilitated through the Medical Device Innovation Consortium (MDIC) that evaluates medical device manufacturers' capabilities and performance using third-party appraisals. The program aims to guide improvement and enhance device quality through assessment against best practices outlined in the CMMI model.

  1. Review eligibility criteria and apply through the VIP application portal if qualified
  2. Prepare for and undergo initial MDDAP appraisal within 90 days of enrollment
  3. Establish processes to:
    • Conduct annual appraisals
    • Participate in quarterly progress check-ins
    • Track and report quality performance measures
    • Maintain proactive communication with FDA on safety issues
  4. Document quality performance measures across required domains (safety, effectiveness, reliability, availability)
  5. Maintain compliance with all applicable regulations while participating in the program
  6. Consider utilizing modified submission formats for eligible PMA/HDE submissions if qualified
  7. Establish internal processes to monitor and maintain program participation requirements to avoid potential removal
  8. Develop communication protocols for engaging with FDA and appraisers throughout participation

Key Considerations

Safety

  • Participants must proactively notify FDA regarding product safety issues or recalls following all current regulatory requirements
  • Issues related to safety brought to FDA’s attention during participation require collaboration to mitigate impact and implement effective resolution

Other considerations

  • ISO 13485: Medical devices - Quality management systems for regulatory purposes
  • CMMI (Capability Maturity Model Integration): Framework for process improvement

Original guidance

  • Voluntary Improvement Program (VIP) for Medical Device Manufacturers: Participation Requirements and Implementation
  • HTML / PDF
  • Issue date: 2023-09-15
  • Last changed date: 2023-09-14
  • Status: FINAL
  • Official FDA topics: Medical Devices, Current Good Manufacturing Practice (CGMP), Postmarket
  • ReguVirta summary file ID: c460f5e4cf80c5d3e9627652600cb022
This post is licensed under CC BY 4.0 by the author.