FDA’s final guidance clarifies participation in medical device Voluntary Improvement Program

The US Food and Drug Administration (FDA) has finalized its guidance for industry on engaging with the Voluntary Improvement Program (VIP), clarifying that the program does not replace FDA inspections, addressing public comments on how participants could benefit from the program, and elaborating on the agency’s role in the program.

VIP is managed by the Medical Device Innovation Consortium (MDIC) and based on the Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program, uses an appraisal similar to the Information Systems Audit and Control Association (ISACA) Capability Maturity Model Integration (CMMI) system for medical device industry participants to evaluate strengths and identify areas of improvement.

While MDIC shares some de-identified data with the FDA, FDA representatives are present on the VIP governance committee, and FDA provides input on VIP’s operations and changes, the agency has emphasized the program is not a regulatory inspection or audit (RELATED: FDA drafts guidance on medical device voluntary improvement program, Regulatory Focus 9 May 2022).

“Appraisers do not make regulatory observations or findings. Although the VIP produces information conveyed to both the firm and to FDA, it does not issue a rating or a certification,” the agency wrote in the guidance.

In public comments, industry stakeholders expressed an interest in learning more about how FDA is engaging with the VIP, the benefits for participating, and how the program fits in with regulatory programs. The changes in the final guidance provide additional information in these areas as well as addressing some minor issues industry stakeholders had with the draft guidance (RELATED: Stakeholders seek tweaks to FDA’s voluntary improvement program guidance, Regulatory Focus 09 July 2022).

Changes from draft guidance

The final guidance includes changes to the wording for the description of the Medical Device Discovery Appraisal Program (MDDAP) model, modifying it to “Governance, Implementation Infrastructure, and Managing Performance and Measurement” from practice areas of “Estimating, Planning, and Configuration Management” initially proposed by FDA. The agency also noted that VIP participants could “adjust the practice areas on the subsequent appraisals compared to the baseline set to better align with the organizational improvement goals.”

The agency also took the opportunity to reemphasize in several areas that the VIP is not a regulatory requirement, nor is it an inspection. “FDA retains the inspection authority granted under the FD&C Act and may conduct inspections at VIP sites, including, but not limited to surveillance, premarket, or for cause inspections as appropriate,” they said.

When describing the appraisal process, they clarified the nature of appraisals by removing a line about third-party appraisers not collecting data during their visit. “As part of the appraisal process, appraisers may review relevant information including, but not limited to, documents and systems, and conduct interviews,” FDA wrote. The data shared with FDA is de-identified, aggregate information, the agency explained, such as “high-level appraisal scores for each assessed practice area, by firm name and location.”

Regarding VIP operations, the agency said despite not considering regulatory compliance as part of VIP, they still review a manufacturer’s business processes “to determine if they support ongoing achievement of business objectives, including quality improvements.”

FDA also shortened the review time for 30-day change notices for modifications to manufacturing procedures or methods of manufacture, reducing it from 14 days in the draft guidance to 10 days in the final guidance.

Other additions

In a section describing VIP operations, FDA switched a mention of the MDDAP program administrator from the CMMI Institute to ISACA, which acquired the CMMI Institute in 2016. FDA describes ISACA as “an independent body” with “established certification procedures to prevent conflicts of interest for the third-party appraisers.”

Another addition to the final guidance is a recognition from FDA that there “are other potentially viable appraisal programs and may consider assessing those programs and their suitability for future use in the VIP.”

Concerning VIP eligibility, FDA added a clarifying line that eligibility is determined by compliance with the FD&C Act and associated regulations and that the agency may use decide on eligibility using the firm’s inspectional history and “other relevant information.”

FDA also noted in their VIP process flow that they may use recommendations from third-party appraisal programs “regarding frequency of these activities (appraisals, check-ins, and submission of quality performance measures) as participants demonstrate continuing engagement, increased performance, or capability in their business process.”

Final guidance
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FDA’s final guidance clarifies participation in medical device Voluntary Improvement Program

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