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.
What You Need to Know? 👇
What is the FDA’s Voluntary Improvement Program (VIP) for medical devices?
The VIP is a voluntary program facilitated through MDIC that uses third-party appraisals to evaluate medical device manufacturers’ business processes against CMMI best practices, aiming to improve device quality and manufacturing capabilities.
What benefits can manufacturers receive from participating in the VIP?
Participants may receive consideration in FDA’s risk-based inspection planning, opportunities to use modified submission formats for PMA/HDE changes, and expedited review timelines for certain manufacturing modifications and site changes.
How does VIP participation affect FDA inspection requirements?
VIP participation doesn’t eliminate FDA inspection authority. However, FDA may consider VIP appraisal information in risk-based inspection planning while retaining full discretion to conduct surveillance, premarket, or for-cause inspections as appropriate.
What are the key eligibility requirements for VIP enrollment?
Manufacturers must have a history of compliance with FD&C Act requirements, be regulated by CDRH, and meet specified enrollment criteria. FDA reviews applications within 5 calendar days to confirm eligibility.
How often are VIP appraisals conducted and what do they involve?
Participating sites receive annual MDDAP appraisals conducted by certified third-party appraisers, quarterly progress check-ins, and must submit quality performance measures. Appraisals evaluate business processes against CMMI best practices, not regulatory compliance.
Can manufacturers withdraw from the VIP and what are the consequences?
Yes, participation is voluntary and manufacturers can withdraw anytime by notifying the third-party appraisal program or FDA. Withdrawal affects access to program opportunities, but participants may be eligible to re-enroll later.
What You Need to Do 👇
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 ID: c460f5e4cf80c5d3e9627652600cb022