On May 5, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance regarding the FDA’s Voluntary Improvement Program (“VIP”). The draft guidance, Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program, can be found here.  According to the FDA:

“The VIP is a voluntary program facilitated through the Medical Device Innovation Consortium (MDIC) that evaluates the capability and performance of a medical device manufacturer’s practices using third-party appraisals, and is intended to guide improvement to enhance the quality of devices.”

The VIP draft guidance, is an extension of the 2018 pilot program Case for Quality Voluntary Medical Device Manufacturing and Product Quality (“CfQ Pilot Program”). According to the FDA, the CfQ Pilot Program assessed the “capability and performance of key business processes using a series of integrated best practices detailed in the Information Systems Audit and Control Association (ISACA) Capability Maturity Model Integration (CMMI) system.” The results of the pilot program can be found here.  Participants in the CfQ Pilot Program reported that “the appraisal had a direct value to product quality and over 90% reported a positive experience with the appraisal.”

As described in the draft guidance, the goal of the VIP is to “elevate and enhance manufacturing practices and behaviors through which quality and safety of medical devices can be improved.” As indicated in its name, this program is voluntary. Through use of the program, third-party appraisers visit participants to evaluate their practices in order to identify strengths and areas for improvement.

According to the draft guidance, VIP offers various benefits and opportunities for those manufacturing sites who demonstrate sustained capability and performance. Examples of opportunities from the draft guidance include:

• FDA Consideration in Risk-Based Inspection Planning
• Utilization of a Modified Submission Format for Premarket Approval Application (PMA) and Humanitarian Device Exemption (HDE) 30-Day Change Notices for Modifications to Manufacturing Procedures or Methods of Manufacture
• Utilization of a Modified Submission Format for PMA and HDE Manufacturing Site Change Supplements
• Utilization of a Modified Submission Format for PMA or HDE – Manufacturing Modules

The VIP has various participation and enrollment criteria for manufacturing sites, which can be found here.

The FDA requests comments on the draft guidance by July 5, 2022.