The first Case for Quality program to be supported by FDA via final guidance is set to expand
Schaumburg, IL—The United States Food and Drug Administration (FDA) has announced its support of the 自愿改善计划 (VIP) through final Guidance 2023年9月14日出版. 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.
The Case for Quality collaborative community VIP was developed in collaboration with the medical device industry, FDA, 医疗仪器创新联盟(MDIC) and ISACA. VIP利用ISACA的医疗器械发现评估计划(MDDAP), a tailored version of the Capability Maturity Model Integration (CMMI)架构及评估方法, 以帮助医疗器械制造商更好地了解, measure and improve their capabilities to deliver high quality products. VIP, 这是通过医疗保险来促进的吗, 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, 例如30天的变更通知, 现场变更及制造模块:
- Inspections: Program engagement informs a risk-based approach to FDA inspection planning and resource allocation for routine surveillance, 批准前和上市后检查.
- 30天变更通知: 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.
- 制造模块: 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. 最后以VIP为指导发布, CDRH has published policy leveraging the third-party maturity appraisal in its day-to-day operations,西斯科·维森蒂说, 质量项目经理的案例, FDA CDRH, 在FDA的声明中. “这一里程碑确立了我们对VIP的承诺, 使程序能够增长, and provides CDRH a foundation to implement additional improvements in our goals to improve the quality and safety of medical devices. 这是一个非常令人兴奋的机会.”
“Supporting manufacturers in their pursuit of continuous improvement is foundational to the MDIC mission,安德鲁·费什说, 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, 提高运营效率, 甚至提高病人的安全. 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, 其中包括与个人贡献者的对话, 系统演示, 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. 在初始基线评估之后, subsequent yearly appraisals allow manufacturers to align their VIP quarterly checkpoint objectives to their business goals.
- 日产量增加65%
- 处理投诉的时间缩短了27%
- 4 times increase in production capacity (which in turn increased revenue)
- 不合格率降低66%
- 执行不力的成本同比减少32%
- 员工流动率降低70%
“这次与ISACA的有效合作, the FDA and MDIC will help device makers deliver their products to patients faster and at a higher level of quality through VIP,Erik Prusch说, 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, 请阅读FDA的联邦注册公告 http://www.fda.gov/regulatory-information/search-fda-guidance-documents/fostering-medical-device-improvement-fda-activities-and-engagement-voluntary-improvement-program.
更多关于MDDAP的细节可以在 jpkq.shadleysoapstone.com/mddap，有关CMMI的信息可在 jpkq.shadleysoapstone.com/enterprise/performance-improvement-solutions. 要了解更多关于“质量案例”访问的信息 http://mdic.org/program/case-for-quality/.
About ISACA
ISACA® (jpkq.shadleysoapstone.com) is a global community advancing individuals and organizations in their pursuit of digital trust. 50多年了, ISACA为个人和澳门赌场官方下载提供了相关知识, credentials, education, 培训和澳门赌场官方下载发展他们的事业, 改变他们的组织, 建立一个更可信、更有道德的数字世界. ISACA is a global professional association and learning organization that leverages the expertise of its more than 170,000 members who work in digital trust fields such as information security, governance, assurance, risk, 隐私和质量. It has a presence in 188 countries, including 225 chapters worldwide. 通过其基金会One In Tech, ISACA supports IT education and career pathways for underresourced and underrepresented populations.
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Media Contacts
Emily Ayala, eayala@shadleysoapstone.com, +1.847.385.7223
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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, 以及其他机构, industry, non-profits, and patient advocacy organizations to improve the processes for development, assessment, 以及对新医疗技术的回顾. MDIC协调各种方法的开发, tools, and resources used in managing the total product life cycle of a medical device to improve patient access to cutting-edge medical technology.
Contact: Matthew Victoria, mvictoria@mdic.org
