FDA Drafts Medical Device Voluntary Improvement Program Guidance

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Posted on May 09, 2022 | By Mary Ellen Schneider

The U.S. Food and Drug Administration (FDA) has released draft guidelines outlining the agency’s participation in an ongoing voluntary medical device improvement program (VIP) that uses third-party assessments to assess medical device practices. manufacturing.

The VIP is managed by the Medical Device Innovation Consortium (MDIC) and builds on the experience of the Case for Quality Voluntary Medical Device Manufacturing and Product Quality pilot program.

As in the pilot program, VIP oversees third-party assessors who assess industry participants using best practices from the Systems Auditing and Monitoring Association’s Capability Maturity Model Integration (CMMI) system. information (ISACA). VIP uses a version of the CMMI assessment tailored to the medical device industry, covering 11 practice areas including estimating, planning, and configuration management.

Based on the assessment, VIP identifies the manufacturer’s strengths and areas for improvement and certain de-identified aggregate information is shared with the FDA.

“The site visit and/or analysis is not intended to be a regulatory inspection or audit, and the assessors do not assess the company’s compliance with applicable regulatory standards. Evaluators do not collect evidence during their site visit and do not make regulatory observations or findings. Although the VIP produces information that is reported to both the company and the FDA, it does not issue a rating or certification,” the agency wrote in the draft guidelines.

Pilot lessons

In 2018, the FDA and MDIC launched a voluntary pilot program at medical device manufacturing sites in which certified third-party teams would perform quality system assessments of various processes associated with quality and performance goals. During the pilot, participating sites agreed to work with the FDA’s Center for Devices and Radiological Health (CDRH) and submit post-evaluation baseline measurements to track progress on a quarterly basis. Device makers have covered their own evaluation costs (RELATED: FDA Details New Manufacturing Quality Pilot Program, Regulatory guidance January 15, 2018).

The pilot project had 46 active participating sites and more than 80% of participants surveyed said the assessment had direct value related to improving product quality. Based on the results of the pilot project, it is transitioning to a permanent program, called Case for Quality Voluntary Improvement Program (CfQVIP).

Guidance details

According to the draft guidelines, participating manufacturing sites that exhibit sustainable capabilities or improvements may choose to take advantage of several opportunities, including consideration by FDA in risk-based inspection planning, use of ‘a modified submission format for the Premarket Approval (PMA) Application and Humanitarian Device Exemption (HDE) 30-day Notice of Change for changes in manufacturing procedures or manufacturing methods, the use of modified submission format for PMA and HDE Manufacturing Site Change Supplements and use of modified submission format for PMA or HDE Manufacturing Modules.

The agency will maintain its representation on the VIP governance committee and will contribute to the operation and changes of the program. The draft guidance also notes that FDA will engage with participating manufacturing sites to discuss and resolve issues brought to the agency’s attention during an assessment. “If there is no resolution for these issues, the evaluation must end and the participant may no longer continue to participate in the program,” according to the draft guidelines.

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