The first Case for Quality program to be supported by FDA via final guidance is set to expand

The United States Food and Drug Administration (FDA) has announced its support of the Voluntary Improvement Program (VIP) through final Guidance published 14 September 2023. 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 treatments to patients.

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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.

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 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,” said Cisco Vicenty, Case for Quality Program Manager, FDA CDRH, in an FDA 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.”

“Supporting manufacturers in their pursuit of continuous improvement is foundational to the MDIC mission,” said Andrew Fish, President & CEO of MDIC. “The VIP program’s impact has been growing steadily as more and 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.”

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 allow 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:

• 65 percent increase in daily production
• 27 percent decrease in time to close complaints
• 4 times increase in production capacity (which in turn increased revenue)
• 66 percent reduction in non-conformances
• 32 percent reduction year over year in cost of poor execution
• 70 percent 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,” says Erik Prusch, ISACA CEO. “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 anticipated to grow. To learn more, including which manufacturers are currently eligible to participate in the voluntary program, read the FDA’s federal register notice at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fostering-medical-device-improvement-fda-activities-and-engagement-voluntary-improvement-program.

More detail on MDDAP can be found at www.isaca.org/mddap, and information on CMMI can be found at www.isaca.org/enterprise/performance-improvement-solutions. To learn more about the Case for Quality visit https://mdic.org/program/case-for-quality/.

About ISACA

ISACA^® (www.isaca.org) 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.

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About MDIC

The Medical Device Innovation Consortium (MDIC) is a public-private partnership that brings together representatives of the FDA, NIH, CMS, NIST, and other agencies, industry, non-profits, and patient advocacy organizations to improve the processes for development, assessment, and review of new medical technologies. MDIC coordinates the development of methods, tools, and resources used in managing the total product life cycle of a medical device to improve patient access to cutting-edge medical technology.

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FDA announces formal support for Voluntary Improvement Program (VIP).