Key Takeaways
- FDA Voluntary Improvement Program (VIP) is a voluntary initiative facilitated through the Medical Device Innovation Consortium (MDIC) that uses third-party appraisals to help medical device manufacturers improve quality and accelerate innovation
- Regulatory benefits include risk-based inspection planning, streamlined submission processes, and faster review times for manufacturing changes
- Operational improvements demonstrated by participants include increased production capacity, reduced staff turnover, and significant time savings
- FDA Voluntary Improvement Program eligibility is limited to manufacturers of FDA-regulated devices with established compliance profiles and not under Official Action Indicated (OAI) status
- The FDA VIP program uses MDDAP, a specialized CMMI framework covering 11 practice areas to assess and improve organizational capabilities
- Final FDA guidance was published in September 2023, establishing formal agency support and enabling program expansion
- Multi-stakeholder approach involves FDA CDRH, MDIC, ISACA, and Performance Review Institute working together to support participants
- Measurable FDA VIP results include a systemic downward recall trend among participating facilities, demonstrating real-world impact on patient safety
What is the FDA Voluntary Improvement Program?
The FDA Voluntary Improvement Program (VIP) represents a transformative approach to medical device quality management. The FDA VIP program builds on the framework piloted through FDA's 2018 Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program, incorporating lessons learned and successes from that initial effort.
The medical device industry faces mounting pressure to deliver higher-quality products faster while maintaining rigorous safety standards. The FDA Voluntary Improvement Program addresses these challenges through a voluntary initiative facilitated by the Medical Device Innovation Consortium (MDIC) that assesses manufacturer practices using third-party appraisals to enhance device quality and accelerate innovation.
For medical device manufacturers seeking to move beyond basic compliance and establish themselves as industry leaders in quality management, the FDA VIP program represents a groundbreaking opportunity to gain competitive advantages while contributing to better patient outcomes.
Understanding the FDA VIP Framework
The FDA Voluntary Improvement Program transitioned from pilot status to full operation in 2021, and the FDA published final guidance supporting the FDA VIP in September 2023. This milestone established the agency's long-term commitment to the program and enabled expansion opportunities.
At its core, the FDA Voluntary Improvement Program uses a specialized version of the Capability Maturity Model Integration (CMMI) framework called the Medical Device Discovery Appraisal Program (MDDAP). The baseline FDA VIP appraisal using the MDDAP model covers 11 practice areas, including:
- Governance and organizational leadership
- Implementation infrastructure and resources
- Managing performance and measurement systems
- Process optimization and control
- Risk management integration
- Supplier relationship management
- Configuration and change management
- Quality system effectiveness
- Data integrity and analysis
- Continuous improvement culture
- Stakeholder engagement
These practice areas provide FDA Voluntary Improvement Program participants with a comprehensive roadmap for quality improvement that goes far beyond traditional compliance checklists.
FDA Voluntary Improvement Program Benefits: Regulatory Advantages
One of the most compelling aspects of the FDA VIP is the potential for regulatory opportunities to help accelerate improvements to device quality and manufacturing. Qualified FDA Voluntary Improvement Program participants may receive:
Risk-Based Inspection Planning
FDA VIP program engagement informs FDA's approach to inspection planning and resource allocation for routine surveillance, preapproval, and post-market inspections. This risk-based approach recognizes the enhanced quality systems of participating manufacturers.
Streamlined FDA VIP Submissions
The FDA Voluntary Improvement Program offers modified submission formats with reduced timeframes for:
- Premarket Approval Application (PMA) and Humanitarian Device Exemption (HDE) 30-Day Change Notices
- Manufacturing site change supplements with accelerated review processes
- PMA or HDE Manufacturing Modules with simplified submission formats
These FDA VIP regulatory efficiencies can significantly reduce time-to-market for product improvements and manufacturing changes, providing competitive advantages in fast-moving markets.
FDA VIP Operational and Business Benefits
Beyond regulatory advantages, manufacturers participating in the FDA Voluntary Improvement Program report substantial operational improvements that directly impact the bottom line.
Device manufacturers participating in the FDA VIP continuously demonstrate improved product safety, increased speed to market, operational savings, enhanced revenue opportunities, and where applicable, decreased regulatory burdens. Real-world FDA Voluntary Improvement Program results include:
- Significant increases in production capacity (some participants report 20-30% improvements)
- Dramatic reductions in staff turnover rates (improving workforce stability)
- Substantial time savings in personnel hours (freeing resources for innovation)
- Enhanced supplier relationships and supply chain resilience
- Improved cross-functional collaboration and communication
- Stronger data-driven decision-making capabilities
The FDA VIP program also strengthens relationships with regulators. As one participating company noted, the FDA Voluntary Improvement Program has enabled them to establish new relationships with peer companies for sharing best practices while strengthening their relationship with FDA, ultimately benefiting patients and customers worldwide.
FDA Voluntary Improvement Program Quality Culture Transformation
The FDA VIP goes beyond traditional compliance audits by fostering a culture of continuous improvement. The FDA Voluntary Improvement Program provides participating manufacturers with detailed data reflecting organizational performance against proven best practices, creating a clear roadmap for enhancement.
Through quarterly checkpoints and performance tracking, FDA VIP companies can monitor progress on improvement projects and prioritize initiatives aligned with their business objectives. This structured approach to quality management helps organizations:
- Identify systemic issues before they become compliance problems
- Benchmark performance against industry best practices
- Create accountability for quality improvements across all levels
- Build sustainable quality systems that adapt to changing requirements
- Develop talent through exposure to advanced quality methodologies
The FDA Voluntary Improvement Program's emphasis on organizational maturity rather than just process compliance creates lasting cultural change that persists beyond individual projects or personnel changes.
FDA VIP Eligibility Requirements
This voluntary FDA program is currently only available to eligible manufacturers of medical devices regulated by CDRH. FDA Voluntary Improvement Program eligibility requirements include:
Manufacturing Facility Requirements
- FDA VIP eligible facilities must be part of the lifecycle for medical devices distributed in the United States (Class I, II, or III)
- Companies with prior compliance history or compliance profile, such as US FDA inspection or MDSAP audit
- FDA Voluntary Improvement Program facilities not under Official Action Indicated (OAI) status or subject to judicial action (Voluntary Action Indicated status is acceptable)
- Organizations performing functions such as contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development
Special Circumstances for FDA VIP
New manufacturers, startups, companies without a compliance profile, or those not currently marketing products in the U.S. should seek additional FDA Voluntary Improvement Program eligibility information through the FDA guidance document or contact the Case for Quality team at [email protected].
The FDA VIP Appraisal Process Explained
The FDA Voluntary Improvement Program appraisal process involves experienced teams evaluating organizational capabilities through multiple methods designed to provide comprehensive insights into quality system maturity.
FDA VIP Assessment Methods
The FDA Voluntary Improvement Program appraisal includes:
Conversations and Interviews: Discussions with individual contributors across various organizational levels provide perspective on how quality systems function in daily operations.
System Demonstrations: Live demonstrations showing processes in action validate that documented procedures align with actual practices.
Site Tours: Physical examinations of manufacturing operations and workflows reveal how quality is maintained across different environments.
Evidence Review: Documentation and records are evaluated against CMMI best practices to assess system robustness.
The FDA VIP appraisal results provide organizations with actionable insights to identify strengths and improvement opportunities. Rather than simply highlighting deficiencies, the FDA Voluntary Improvement Program appraisal creates a strategic framework for prioritizing enhancements that align with business objectives and quality goals.
FDA Voluntary Improvement Program Structure and Support
The FDA VIP is facilitated through a collaborative community including multiple key stakeholders:
FDA Center for Devices and Radiological Health (CDRH)
The FDA CDRH provides regulatory oversight for the FDA Voluntary Improvement Program and defines opportunities for participants. The agency's commitment ensures that FDA VIP benefits remain aligned with regulatory science and patient safety priorities.
Medical Device Innovation Consortium (MDIC)
MDIC facilitates FDA Voluntary Improvement Program operations and creates a collaborative space for industry and agency cooperation. This neutral convener role ensures that the FDA VIP serves the broader medical device ecosystem.
ISACA
ISACA delivers the MDDAP framework for the FDA Voluntary Improvement Program and trains certified appraisers who conduct facility assessments. Their expertise in capability maturity models ensures consistency across FDA VIP appraisals.
Performance Review Institute (PRI)
PRI recently joined as an FDA Voluntary Improvement Program implementing partner to expand program access and provide additional appraisal capacity as the FDA VIP grows.
This multi-stakeholder approach ensures that the FDA Voluntary Improvement Program benefits from diverse perspectives while maintaining alignment with regulatory goals and industry needs.
FDA VIP Impact on the Healthcare Ecosystem
The FDA Voluntary Improvement Program benefits the entire healthcare ecosystem, not just individual participants. Suppliers, OEMs, contract manufacturers, and sterilizers all benefit from resilient supply chains, better quality and more efficient production enabled by the FDA VIP.
By raising quality standards throughout the supply chain, the FDA Voluntary Improvement Program contributes to systemic improvements that ultimately enhance patient safety and treatment outcomes. When multiple organizations in a supply network participate in the FDA VIP, the cumulative effect creates more robust and reliable device availability.
The FDA Voluntary Improvement Program has demonstrated measurable results, with the FDA noting a systemic downward recall trend in participating facilities. This evidence supports the FDA VIP's core premise that focusing on continuous improvement and quality culture delivers tangible benefits for both manufacturers and patients.
FDA Voluntary Improvement Program: Looking Forward to 2025 and Beyond
With formal FDA support now established through final guidance, the FDA Voluntary Improvement Program is positioned for significant expansion in 2025. As Cisco Vicenty, Case for Quality Program Manager at FDA CDRH, stated in an FDA announcement, this milestone establishes the agency's commitment to the FDA VIP, enables program growth, and provides CDRH a foundation to implement additional improvements toward enhancing medical device quality and safety.
For medical device manufacturers committed to excellence, the FDA Voluntary Improvement Program offers a unique opportunity to differentiate themselves in a competitive market while contributing to the broader goal of delivering safer, higher-quality medical devices to patients faster.
Future FDA VIP Developments
Industry observers expect the FDA Voluntary Improvement Program to continue evolving with potential enhancements such as:
- Expanded eligibility criteria to include more device types and manufacturers
- Additional regulatory opportunities for high-performing FDA VIP participants
- Integration with other FDA quality initiatives and programs
- Enhanced data sharing and benchmarking capabilities across FDA VIP participants
- Possible international recognition or harmonization with global quality programs
FDA Voluntary Improvement Program Success Stories
Organizations that have participated in the FDA VIP consistently report transformative results. While specific company names are often kept confidential to protect competitive information, the patterns of improvement are clear and consistent across FDA Voluntary Improvement Program participants.
Manufacturing Excellence Improvements
FDA VIP participants have reported production capacity increases of 20-30% without additional capital investment, simply by optimizing processes and reducing variability. These improvements demonstrate how the FDA Voluntary Improvement Program's focus on system maturity translates directly to business performance.
Workforce Stability Enhancement
Staff turnover rates at FDA Voluntary Improvement Program facilities have decreased dramatically, with some organizations reporting 40-50% reductions in voluntary departures. This stability contributes to institutional knowledge retention and consistent quality performance.
Regulatory Efficiency Gains
FDA VIP participants report faster approval times for submissions, fewer inspection observations, and more productive relationships with FDA reviewers who understand their commitment to quality excellence.
How to Get Started with the FDA Voluntary Improvement Program
Organizations interested in the FDA VIP should follow these steps:
Step 1: Assess FDA VIP Eligibility
Review the FDA Voluntary Improvement Program eligibility requirements outlined in the FDA guidance document. Ensure your facility has an established compliance profile and is not under OAI status.
Step 2: Contact the FDA VIP Team
Reach out to the Case for Quality team at [email protected] to express interest and discuss your organization's readiness for the FDA Voluntary Improvement Program.
Step 3: Prepare for FDA VIP Engagement
Begin internal assessments of your quality systems against the MDDAP practice areas. Identify potential champions who can lead the FDA Voluntary Improvement Program initiative within your organization.
Step 4: Engage with MDIC
Connect with the Medical Device Innovation Consortium to understand the FDA VIP community, access resources, and learn from other participants' experiences.
Step 5: Schedule FDA VIP Appraisal
Work with ISACA or PRI to schedule your baseline FDA Voluntary Improvement Program appraisal and begin the journey toward continuous improvement.
FDA Voluntary Improvement Program: Frequently Asked Questions
Is the FDA VIP mandatory?
No, the FDA Voluntary Improvement Program is completely voluntary. Manufacturers choose to participate based on their quality improvement goals and desire for enhanced regulatory engagement.
How much does FDA VIP participation cost?
While the FDA Voluntary Improvement Program itself is free, organizations pay for third-party appraisals conducted by ISACA or PRI-certified assessors. Costs vary based on facility size and complexity.
How long does an FDA VIP appraisal take?
A typical FDA Voluntary Improvement Program baseline appraisal takes 3-5 days on-site, depending on facility size and organizational complexity. Preparation time varies by organization.
Can international facilities participate in the FDA VIP?
Yes, if the FDA Voluntary Improvement Program facility manufactures devices distributed in the United States and meets other eligibility requirements, international facilities can participate.
What happens if we don't score well on the FDA VIP appraisal?
The FDA Voluntary Improvement Program is focused on improvement, not punishment. Lower maturity scores simply identify opportunities for enhancement and create a roadmap for progress.
Conclusion: Embracing the FDA Voluntary Improvement Program
The FDA Voluntary Improvement Program represents a paradigm shift from reactive compliance to proactive quality management. By participating in the FDA VIP, medical device manufacturers gain access to proven best practices, regulatory efficiencies, and a supportive collaborative community focused on continuous improvement.
As the FDA Voluntary Improvement Program continues to grow and evolve, it promises to reshape how the industry approaches quality management—moving beyond minimum regulatory requirements to embrace excellence as a competitive advantage and patient safety imperative.
The FDA VIP demonstrates that quality and efficiency are not competing priorities but complementary goals. Organizations that invest in building mature quality systems through the FDA Voluntary Improvement Program find that they can move faster, innovate more effectively, and serve patients better than those who view quality as merely a compliance burden.
For forward-thinking medical device manufacturers in 2025 and beyond, the FDA Voluntary Improvement Program offers a clear path to operational excellence, regulatory efficiency, and market leadership—all while advancing the fundamental mission of delivering safe, effective medical devices to patients who need them.
FDA Voluntary Improvement Program Additional Resources
- FDA Official Guidance on VIP – Complete guidance document for FDA Voluntary Improvement Program participation
- FDA VIP Program Information – Official FDA Voluntary Improvement Program overview and updates
- Medical Device Innovation Consortium (MDIC) VIP Page – FDA VIP facilitation and community resources
- ISACA VIP Information and Resources – FDA Voluntary Improvement Program appraisal methodology and training
- Performance Review Institute VIP Program – Additional FDA VIP appraisal services
- Federal Register Notice – Official FDA VIP final guidance publication
Contact for FDA Voluntary Improvement Program Questions: [email protected]
