Regulatory affairs within the medtech industry is uniquely challenging. Teams are faced with external changes in the form of new regulations (such as the MDR/IVDR in the European Union), growing information needs (including expanding unique device identification requirements around the world), newer audit requirements (MDSAP), and post-market surveillance requirements.
While there are emerging technologies that can help teams better address these issues, building more effective and efficient regulatory teams requires more than better tools. The traditional, largely manual approach to regulatory procedures and processes must also evolve, including the measurement of regulatory maturity. The Medical Device Discovery Appraisal Program (MDDAP) was born out of the recognition that regulatory compliance does not, by itself, guarantee the highest quality devices and was designed to enable device makers to measure their capability to produce high-quality devices.
This blog post provides a high-level overview of the Medical Device Discovery Appraisal Program (MDDAP) to help organizations assess the benefits of participating.
MDDAP provides the model for the Case for Quality Voluntary Improvement Program, a collaborative program between the FDA Center for Devices and Radiological Health (CDRH), the Medical Device Innovation Consortium (MDIC), Information Systems Audit and Control Association (ISACA), and the medical device industry. The Case for Quality program was initially started by the FDA in 2011 to identify manufacturers that consistently produce high-quality devices along with the practices that have the greatest impact on quality.
A timeline of MDDAP:
The draft guidance issued in May, 2022 outlines the transition from the pilot program to a permanent program, titled the Case for Quality Voluntary Improvement Program. The Voluntary Improvement Program (VIP) is facilitated through the Medical Device Innovation Consortium (MDIC) which will utilize the Capability Maturity Model Integration (CMMI) to evaluate the capability and performance of the participating medical device manufacturers. Originally developed to optimize an organization’s software development process, CMMI is now used in many industries to provide a methodology and assessment tools for continuous improvement.
The MDDAP program is voluntary and leverages the CMMI model to provide medical device manufacturers, who are already in compliance with FDA quality and regulatory requirements, with insight into how they perform against selected best practices. The program is designed to help already-compliant organizations identify gaps in existing processes and increase the ability to react to change and avoid previously unforeseen quality and process issues.
Any facility which “designs, manufacturers, fabricates, assembles, or processes a finished device” in the United States is eligible for participation, with the following additional requirements:
Participants in the program can include those with Class I, II, or III devices and, in addition to being device manufacturers, may also perform contract sterilization, relabeling, remanufacturing, repacking, or specification development.
Visit the ISACA MDDAP site to see if your organization qualifies.
The MDDAP program provides operational advantages by streamlining multiple regulatory processes with the FDA, as well as longer-term benefits to product quality and organizational processes. The program is built on the CMMI framework which identifies processes most effective in decreasing risk and improving product quality.
MDDAP participants who have completed appraisals through the program will have the following advantages when working with the FDA:
1. Reduced inspection activities - A risk-based approach to FDA inspections allows manufacturers to bypass routine FDA surveillance audits and PMA preapproval inspections for participating sites. The participating site will have demonstrated compliance with the quality system regulations verified by FDA through inspection (a prerequisite for joining the program). MDDAP appraisals and quarterly checkpoints evaluate the participating organization against a proven set of best practices and provide guidance on continuous improvement projects.
Participants should understand that the FDA will still perform “for cause” or directed inspections as required based on safety signals or as a follow-up to a safety event. Also, note that organizations participating in the MDSAP program will still need MDSAP audits.
2. Streamlined change notices - Participants in the MDDAP program have access to modified submission formats for:
3. A more collaborative process with the FDA - The FDA’s Case for Quality program was designed to provide a more collaborative approach to medical device compliance and quality. This differs from the traditional oversight models by going beyond regulatory compliance and focusing on continuous improvement projects that optimize device quality.
Perhaps the biggest benefit of participating in the MDDAP program, however, is that the program provides a methodology for evaluating an organization's “maturity level” and implementing continuous improvements toward the goal of optimizing quality. Participating organizations are committing to a proven continuous improvement program. This results in the ability to consistently ensure a high-level of quality that can yield significant competitive and market advantages.
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