FDA Announces its Support for Voluntary Improvement Program

The U.S. Food and Drug Administration (FDA) has vocalized its support of the Voluntary Improvement Program (VIP) through final guidance it published this fall. VIP, which transitioned from a pilot to a fully operational program in 2021 and then was formally recognized by the FDA last year, delivers improved organizational and product performance with the ultimate goal of increasing the pace and quantity of providing safe patient treatments.
 
The Case for Quality collaborative community VIP was developed in collaboration with the medical device industry, FDA, the Medical Device Innovation Consortium (MDIC) and ISACA. VIP leverages ISACA’s Medical Device Discovery Appraisal Program (MDDAP), a tailored version of the Capability Maturity Model Integration (CMMI) framework and appraisal methodology, to help medical device manufacturers better understand, measure, and improve their capabilities to deliver high-quality products. VIP, which is facilitated through MDIC, is the first Case for Quality Program recognized by the FDA that offers participants regulatory opportunities to help accelerate improvements to device quality and manufacturing.

“Supporting manufacturers in their pursuit of continuous improvement is foundational to the MDIC mission,” MDIC President/CEO Andrew Fish said. “The VIP program’s impact has been growing steadily as more manufacturers see how they can use this FDA-recognized program to systematically improve quality, improve operational efficiency, and even enhance patient safety. This program is for companies of all sizes and we are excited to see its continued expansion.”
 
These FDA opportunities include those related to risk-based inspection planning and Pre-market Approval submissions for manufacturing, such as 30-Day change notices, site changes and manufacturing modules: 

• Inspections: Program engagement informs a risk-based approach to FDA inspection planning and resource allocation for routine surveillance, preapproval, and post-market inspections.
• 30-Day Change notices: Program data enables the use of a modified submission format with reduced timeframes (resource permitting) for Premarket Approval Application (PMA) and Humanitarian Device Exemption (HDE) 30-Day Change Notices.
• Site changes: Program data enables use of a modified submission format with reduced timeframes (resource permitting) for PMA and HDE Manufacturing Site Change Supplements.
• Manufacturing modules: Program data enables use of a modified submission format for PMA or HDE Manufacturing Modules. 

“VIP has demonstrated that focusing on quality and continuous improvement has impactful results for patients and drives significant value for participating manufacturers. With the release of the final guidance for VIP, CDRH has published policy leveraging the third-party maturity appraisal in its day-to-day operations,” Cisco Vicenty, Case for Quality program manager, FDA CDRH, said in a statement. “This milestone establishes our commitment to VIP, enables the program to grow, and provides CDRH a foundation to implement additional improvements in our goals to improve the quality and safety of medical devices. There is a very exciting opportunity ahead for us.”
 
Through VIP, participating manufacturers engage in a discussion-driven appraisal approach, which involves conversations with individual contributors, systems demonstrations, and site tours. Evidence collected from the discussions is evaluated against the CMMI model of best practices, which identifies the organization’s strengths and areas for improvement. Following an initial baseline appraisal, subsequent yearly appraisals llow manufacturers to align their VIP quarterly checkpoint objectives to their business goals.
 
The program proactively targets improvement efforts that are most impactful, and promotes a more integrated quality culture, increased employee engagement and higher morale. Recent outcomes that device makers have realized after implementing VIP include:

• A 65% increase in daily production
• A 27% decrease in time to close complaints
• A four-fold increase in production capacity (which in turn increased revenue)
• A 66% reduction in non-conformances
• A 32% reduction year over year in cost of poor execution
• A 70% decrease in staff turnover 

“This impactful collaboration with ISACA, the FDA and MDIC will help device makers deliver their products to patients faster and at a higher level of quality through VIP,” ISACA CEO Erik Prusch stated. “Reaching this landmark allows for a stronger infrastructure to expand and scale the program and the meaningful benefits that participating manufacturers are able to achieve—and to ultimately bring improvements that drive improved patient outcomes.”
 
With this milestone, VIP is expected to expand, and participation is anticipated to grow. More information, including the manufacturers currently eligible to participate in the voluntary program, can be found here, while details about the Case for Quality can be found here. 
 
ISACA is a global community advancing individuals and organizations in their pursuit of digital trust. For more than 50 years, ISACA has equipped individuals and enterprises with the knowledge, credentials, education, training and community to progress their careers, transform their organizations, and build a more trusted and ethical digital world. ISACA is a global professional association and learning organization that leverages the expertise of its more than 165,000 members who work in digital trust fields such as information security, governance, assurance, risk, privacy and quality. It has a presence in 188 countries, including 225 chapters worldwide. Through its foundation One In Tech, ISACA supports IT education and career pathways for underresourced and underrepresented populations.