FDA highlights key opportunities offered by VIP, which leverages ISACA’s Medical Device Discovery Appraisal Program (MDDAP).
Schaumburg, IL, USA—The Voluntary Improvement Program (VIP) has become the first Case for Quality program recognized by the United States Food and Drug Administration (FDA) through formal Draft Guidance published 6 May 2022. VIP leverages ISACA’s Medical Device Discovery Appraisal Program (MDDAP) and transitioned from a pilot to a fully operational program last year.
As outlined by the FDA, participants in VIP may benefit from several opportunities to help accelerate improvements to device quality and manufacturing, including:
- Inspections: Program engagement informs a risk-based approach to FDA inspection planning and resource allocation for routine surveillance, pre-approval and post-market inspections.
- 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.
MDDAP provides a model and method by which device makers can understand, measure, and advance their capability to produce high-quality devices which improve patient outcomes. The MDDAP framework, which provides the basis for the VIP, is a version of the ISACA Capability Maturity Model Integration (CMMI) that is customized for this medical device industry program.
Through MDDAP, an experienced appraisal team evaluates an organization’s capabilities through conversations with individual contributors, systems demonstrations, site tours, etc. The results then allow the organization to easily identify areas of strength and opportunities for improvement. With annual MDDAP appraisals against a set of best practices, quarterly check points with performance reports, and a supportive regulatory environment, VIP enables medical device manufacturers to design, build, and deliver safe and innovative products to market faster.
A 2021 survey of VIP participants found that 89 percent believe the MDDAP appraisal identified opportunities to improve product quality and 96 percent believed the appraisal provided broader value add. In one VIP case study, an organization was able to increase production capacity by 65%, getting more treatments to patients faster. Another VIP case study found the organization was able to reduce complaint closure time by 27%, increasing the quality of their products. Many participating organizations in VIP claimed that the program produced a culture shift towards a sustainable quality mindset.
“This announcement from FDA validates the importance of this program,” says Kim Kaplan, ISACA senior product manager – enterprise. “Medical device manufacturers join VIP because of the opportunities outlined by the FDA and then stay in the program because of the benefits they realize from implementing the MDDAP framework throughout the year—including manufacturing improvements, cost reductions, and sustainable holistic solutions.”
“The medical device ecosystem is increasingly complex requiring new tools and approaches to providing the superior products with improved safety expected by patients, health care providers, and regulators. Results from participants in VIP have been impactful and support the concepts and approach developed for the program. This draft guidance is a significant milestone in recognizing the value of collaboration across stakeholders, improved information sharing, and moving beyond the foundational regulatory requirements to improve the quality and safety of medical devices,” says Cisco Vicenty, Case for Quality Program Manager, FDA CDRH.
To read the FDA’s federal register notice, visit https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fostering-medical-device-improvement-fda-activities-and-engagement-voluntary-improvement-program.
To learn more about MDDAP, visit www.isaca.org/mddap.
About ISACA
For more than 50 years, ISACA® (www.isaca.org) has advanced the best talent, expertise and learning in technology. ISACA equips individuals with knowledge, credentials, education and community to progress their careers and transform their organizations, and enables enterprises to train and build quality teams. ISACA is a global professional association and learning organization that leverages the expertise of its more than 150,000 members who work in information security, governance, assurance, risk and privacy to drive innovation through technology. It has a presence in 188 countries, including more than 220 chapters worldwide. In 2020, ISACA launched One In Tech, a philanthropic foundation that supports IT education and career pathways for under-resourced, under-represented populations.
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