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.
Recommended Actions
- Review eligibility criteria and apply through the VIP application portal if qualified
- Prepare for and undergo initial MDDAP appraisal within 90 days of enrollment
- 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
- Document quality performance measures across required domains (safety, effectiveness, reliability, availability)
- Maintain compliance with all applicable regulations while participating in the program
- Consider utilizing modified submission formats for eligible PMA/HDE submissions if qualified
- Establish internal processes to monitor and maintain program participation requirements to avoid potential removal
- 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
- Annual appraisal required for participating sites
- Quarterly progress check-ins with lead appraisers required
- Regular submission of quality performance measures in domains like safety, effectiveness, reliability, and availability
- Participants must engage with appraisers and commit to the mutually agreed appraisal process
- Existing regulatory obligations under FD&C Act remain unchanged
- FDA retains inspection authority and enforcement discretion
Relevant Guidances
- Design Controls for Medical Device Manufacturers
- Quality System Information Requirements for Premarket Submissions
- Least Burdensome Principles for Medical Device Regulation
Related references and norms
- 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
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