FDA Voluntary Improvement Program: A Proven Quality Edge

Medical Device Quality · FDA Case for Quality

The FDA Voluntary Improvement Program is a voluntary, FDA-supported initiative that uses independent third-party appraisals to measure and strengthen the quality maturity of medical device manufacturers — and in 2026, with the FDA's Quality Management System Regulation now built on ISO 13485:2016, it has become one of the clearest ways for a device maker to prove its quality system is more than a binder of policies. This guide explains how the program works, who qualifies, what it delivers, and how it connects to the ISO 13485 system your auditors and regulators now expect.

What Is the FDA Voluntary Improvement Program?

Voluntary. Verified. Value-driven.

The FDA Voluntary Improvement Program grew out of the FDA's Case for Quality initiative, which began with a 2011 study showing that simply being compliant did not reliably predict whether an organization avoided quality problems. The agency wanted a way to look past pass/fail compliance and help manufacturers close the quality gaps that compliance checks were missing. Working with the Medical Device Innovation Consortium (MDIC), the FDA ran a voluntary pilot across medical device manufacturing sites throughout 2018, then transitioned the effort to full operation in 2021.

The program reached a turning point when the FDA published its final guidance, “Fostering Medical Device Improvement,” in September 2023. That guidance describes the agency's policy on participating in the program and signaled a long-term commitment rather than an experiment. The corresponding Federal Register notice formalized the publication and confirmed the program's place in the agency's quality strategy.

At its core, the program is an appraisal model. Rather than inspecting for defects, qualified third-party appraisers evaluate how capably an organization runs the business processes that produce quality — design, production, risk management, supplier control, and the leadership systems that hold them together. The program then identifies strengths and improvement opportunities, and shares high-level results with the FDA. It is explicitly not a substitute for an FDA inspection, and it does not change the agency's enforcement authority. It is a parallel path toward maturity, not a shortcut around the rules.

Why the FDA Voluntary Improvement Program Matters More in 2026

QMSR. ISO 13485. One system.

On February 2, 2026, the FDA's new Quality Management System Regulation (QMSR), codified in 21 CFR Part 820, took effect — replacing the decades-old Quality System Regulation and incorporating ISO 13485:2016 by reference. For United States device manufacturers, ISO 13485 is no longer just an international option. It is the operative regulatory text. FDA investigators now frame inspections and findings in ISO 13485 language, which means the maturity the FDA Voluntary Improvement Program measures and the system the QMSR enforces are now the same system, viewed from two angles.

That convergence reframes the program. A device maker preparing for QMSR-era inspections needs a quality system that holds up under regulatory scrutiny; the FDA Voluntary Improvement Program gives that organization a structured, externally verified way to measure how robust the system actually is and where it will bend under pressure. We break down the regulation itself in our guide to the FDA QMSR rule and its 21 CFR Part 820 / ISO 13485 alignment, and we lay out how to build a system that satisfies FDA, MDSAP, and EU MDR at once on our ISO 13485 medical device consulting page.

The wider 2026 standards landscape reinforces the point. As we cover in what the 2026 ISO revisions mean for certification strategy, ISO 13485 itself was reaffirmed at its 2016 edition rather than rewritten — precisely because so much regulatory machinery, now including the FDA's, depends on its stability. For manufacturers, that stability is an advantage: the target is fixed, and programs like this one help you hit it.

How Does the FDA Voluntary Improvement Program Work?

Appraise. Benchmark. Improve.

The program runs on a tailored version of the Capability Maturity Model Integration (CMMI) framework called the Medical Device Discovery Appraisal Program, or MDDAP. CMMI is a well-established model for measuring how disciplined and consistent an organization's processes are; the MDDAP adaptation aims it specifically at the realities of medical device development and manufacturing. The methodology is delivered and maintained by ISACA, which also trains and certifies the appraisers who conduct facility evaluations.

A baseline appraisal using the MDDAP model covers 11 practice areas that, taken together, describe a mature quality organization:

• Governance and organizational leadership
• Implementation infrastructure and resources
• Managing performance and measurement systems
• Process optimization and control
• Risk management integration
• Supplier relationship management
• Configuration and change management
• Quality system effectiveness
• Data integrity and analysis
• Continuous improvement culture
• Stakeholder engagement

Anyone who has implemented ISO 13485 will recognize this list. It maps almost directly onto the standard's own requirements — leadership and governance under Clause 5, resource and infrastructure under Clause 6, design and production controls under Clause 7, measurement and improvement under Clauses 8 and beyond. That overlap is not a coincidence; it is the reason the program and the standard reinforce each other so cleanly. The appraisal also leans heavily on disciplined corrective action, which we explore in depth in our breakdown of how CAPA works under ISO 13485.

A second implementing partner, the Performance Review Institute (PRI), has joined to expand appraisal capacity as participation grows. Together with the FDA's Center for Devices and Radiological Health (CDRH) providing regulatory oversight and MDIC convening the community, this multi-stakeholder structure keeps the program aligned with regulatory science while remaining genuinely improvement-focused.

FDA Voluntary Improvement Program vs. a Traditional FDA Inspection

Different lens. Different goal.

It is easy to assume the FDA Voluntary Improvement Program is just another audit, but the two activities answer different questions. A traditional FDA inspection asks whether your quality system meets the regulation on the day the investigator arrives — a binary, point-in-time judgment with enforcement consequences attached. The appraisal at the heart of the program asks a different and more forward-looking question: how capably and consistently does your organization run the processes that produce quality over time? One looks for nonconformities; the other measures maturity.

That distinction has practical consequences. An inspection produces findings you must remediate; an appraisal produces a roadmap you choose to act on. An inspection is conducted by the agency under its statutory authority; the appraisal is conducted by independent third parties whose role is to help you improve, with only high-level results shared with the FDA. And while an inspection is something that happens to you, the FDA Voluntary Improvement Program is something you opt into — a deliberate investment in seeing your own system clearly. The program does not replace inspections, and the FDA retains full authority to inspect participating sites. What it adds is a structured way to get ahead of problems before an investigator ever finds them.

For a device maker operating under the QMSR, the two reinforce each other. The maturity the FDA Voluntary Improvement Program builds is exactly what makes a QMSR-era inspection a non-event rather than a scramble. The organizations that fare best under inspection are rarely the ones who studied the regulation hardest the week before — they are the ones whose systems were already mature, documented, and lived-in. That is the muscle the program is designed to build.

What Are the FDA Voluntary Improvement Program Benefits?

Regulatory. Operational. Reputational.

The benefits fall into three groups: regulatory efficiencies, operational gains, and stronger relationships with regulators and peers. On the regulatory side, FDA guidance describes opportunities that participating sites may receive, resources permitting.

Regulatory Advantages

Program participation can inform the FDA's risk-based approach to inspection planning across routine surveillance, pre-approval, and post-market inspections, recognizing the enhanced systems of mature manufacturers. It can also enable modified submission formats with reduced timeframes for certain Premarket Approval (PMA) and Humanitarian Device Exemption (HDE) submissions, including 30-day change notices, manufacturing site change supplements, and manufacturing modules. For organizations whose growth depends on getting manufacturing changes approved quickly, those efficiencies translate directly into time to market.

Operational and Business Gains

Participating manufacturers report improved product safety, faster speed to market, operational savings, and, where applicable, reduced regulatory burden. The implementing partners cite documented savings of more than 1,000 personnel hours and up to 90 percent of dedicated resources on certain processes among participating organizations. Rather than treat any single figure as a guarantee, the more useful pattern is the direction of travel: organizations that invest in maturity typically report fewer repeat findings, shorter corrective-action cycles, and more predictable submissions. MSI client experience suggests the same dynamic in ISO 13485 implementations — the discipline that satisfies an appraiser is the discipline that quietly removes waste.

A Measurable Safety Signal

Perhaps the most compelling evidence is at the system level: the FDA has observed a systemic downward recall trend among participating facilities. That is the outcome the entire Case for Quality initiative was built to produce — proof that focusing on continuous improvement and quality culture delivers real benefits for both manufacturers and the patients who depend on their devices.

Manufacturing and Throughput

Participants in the FDA Voluntary Improvement Program frequently describe gains in production capacity and throughput that come not from new capital equipment but from reduced variability and tighter process control. When a process is well-characterized and consistently run, scrap falls, rework falls, and the line simply produces more good product per shift. Organizations typically report that the discipline of preparing for an appraisal surfaces inefficiencies they had stopped noticing — the small, normalized workarounds that quietly tax every batch.

Workforce Stability and Knowledge Retention

A second pattern participants describe is improved workforce stability. Mature systems reduce the daily friction that drives good people out the door — the firefighting, the ambiguous ownership, the rework that never seems to end. When roles, competence, and process are clearly defined, institutional knowledge stays in the building, and quality performance grows more consistent as a result. MSI client experience suggests the same effect in ISO 13485 implementations: the clearer the system, the less the organization depends on a handful of irreplaceable individuals to keep it running.

Regulatory Efficiency and Trust

Finally, participants report more productive relationships with the FDA. The transparency the program encourages — sharing maturity data, demonstrating a genuine commitment to improvement — builds the kind of trust that pays off when a manufacturing change needs a fast review or an inspection raises a question. As one participating organization put it, the program enabled new peer relationships for sharing best practices while strengthening its relationship with the FDA, ultimately benefiting patients and customers. That trust is not a soft benefit; in a regulated industry, it is operational currency.

Who Is Eligible for the FDA Voluntary Improvement Program?

Regulated. Ready. Eligible.

Eligibility centers on three conditions. First, the facility must be part of the lifecycle for medical devices distributed in the United States and regulated by CDRH. Second, it should have an established compliance history — typically demonstrated through a prior US FDA inspection or a Medical Device Single Audit Program (MDSAP) audit. Third, the site must not be under Official Action Indicated status or subject to judicial action, though Voluntary Action Indicated status does not disqualify a manufacturer.

Organizations performing functions such as contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development can participate. New manufacturers, startups, companies without a compliance profile, or firms not yet marketing in the U.S. are encouraged to seek additional eligibility guidance through the FDA's documentation before applying. A site previously under OAI status can become eligible once corrective actions are implemented and verified by the FDA during a follow-up inspection.

What Happens During an FDA Voluntary Improvement Program Appraisal?

Observe. Verify. Map.

An experienced appraisal team evaluates organizational capability through several complementary methods, each designed to confirm that documented procedures match daily reality rather than simply existing on paper.

Conversations and interviews with individual contributors across organizational levels reveal how the quality system actually functions in day-to-day operations. System demonstrations show processes in action and validate that documented procedures align with practice. Site tours examine manufacturing operations and workflows to see how quality is maintained across different environments. Evidence review evaluates documentation and records against CMMI best practices to gauge how robust the system really is.

Crucially, the appraisal is diagnostic rather than punitive. A typical baseline appraisal runs three to five days on site, and the result is not a grade to fear but a strategic framework for prioritizing the improvements that matter most to your business and quality objectives. Participating sites then engage in quarterly check-ins with their appraisal team to report progress — turning the appraisal into an ongoing improvement relationship rather than a one-time event. This rhythm of audit, verify, and improve is the same discipline we teach in our guide to internal audit follow-up and structure in our approach to internal audit planning.

How the FDA Voluntary Improvement Program Connects to ISO 13485

Build. Mature. Prove.

Here is the practical sequence. You cannot appraise a system you have not built, and the program assumes a functioning quality management system is already in place. That is where ISO 13485 implementation comes first. The standard provides the architecture — design controls under Clause 7.3, risk management aligned to ISO 14971, validation, CAPA, complaint handling, post-market surveillance, and the Medical Device File — and the FDA Voluntary Improvement Program then measures how maturely that architecture operates. Organizations running both ISO 9001 and ISO 13485 gain even more, because the integrated structure carries across systems, as we explain in our ISO consulting decoder ring and in navigating QMS for medical device companies.

This is where Management Systems International (MSI) fits. MSI builds ISO 13485 quality systems around how your team actually designs, manufactures, validates, and ships product — systems engineered to satisfy FDA, MDSAP, and EU MDR simultaneously, without bloating documentation or grinding operations to a halt. A mature, well-documented system is precisely what turns an appraisal from an anxious exercise into a confident demonstration. The same discipline also tightens supplier and supply-chain controls, which we examine in our look at supply chain best practices under ISO 9001 and 13485.

Mapping the 11 Practice Areas to Your ISO 13485 System

Clause by clause. Capability by capability.

The reason the FDA Voluntary Improvement Program feels familiar to anyone with a working quality system is that its 11 MDDAP practice areas are essentially ISO 13485 requirements viewed through a maturity lens. Seeing the overlap makes preparation far less daunting, because most of the evidence an appraiser wants already lives in a well-run quality management system.

Governance and leadership map to ISO 13485 Clause 5, where top management commitment, quality policy, and responsibility are defined. Implementation infrastructure and resources map to Clause 6, covering competence, training, and work environment. Process optimization and control and configuration and change management live in Clause 7's production, design, and change-control provisions. Risk management integration connects Clause 7 design controls to ISO 14971, the risk management standard the FDA recognizes. Supplier relationship management reflects the purchasing and supplier-evaluation requirements that the QMSR scrutinizes closely.

The remaining areas — managing performance and measurement, quality system effectiveness, data integrity and analysis, continuous improvement culture, and stakeholder engagement — correspond to the monitoring, measurement, internal audit, management review, and CAPA machinery that ISO 13485 requires a system to run on an ongoing basis. An organization that already conducts disciplined internal audits, closes corrective actions with verified effectiveness, and feeds the results into management review will recognize most of an FDA Voluntary Improvement Program appraisal as a structured external read of work it already does. Where those mechanisms are weak, the appraisal points precisely at the gap — which is exactly the kind of targeted insight a maturity model is built to deliver.

How to Prepare Your Quality System for an Appraisal

Document. Demonstrate. Rehearse.

Preparation for the FDA Voluntary Improvement Program is less about cramming and more about confirming that the system you have actually operates the way your documentation says it does. Because appraisers use interviews, system demonstrations, and site tours, the question they are really probing is whether procedures and practice match. The most productive preparation, then, is an honest internal read of that alignment.

Three moves do most of the work. First, run a genuine internal audit against each of the practice areas and treat the findings as a gift rather than a threat — better to surface a weak spot yourself than have an appraiser surface it for you. Second, make sure your frontline contributors, not just your quality managers, can describe how the system works in their own words; appraisers talk to the people who do the work, and confident, consistent answers signal a system that is genuinely embedded. Third, tighten the loop between complaints, CAPA, post-market surveillance, and design change, because that closed loop is where maturity is most visible and where ISO 13485 and the QMSR place the heaviest weight.

This is precisely the readiness MSI builds into an ISO 13485 engagement. We train internal auditors on the clauses appraisers and inspectors actually probe, run a full internal audit, and close findings before anyone external walks in the door — so by the time you pursue an FDA Voluntary Improvement Program appraisal, your team already owns the system. Equip them with the ISO 13485 Overview course and the ISO 13485 2-Day Internal Auditor Training, and the preparation stops being a fire drill.

How to Get Started With the FDA Voluntary Improvement Program

Assess. Prepare. Engage.

Organizations interested in the FDA Voluntary Improvement Program generally move through a clear sequence. Begin by reviewing the eligibility requirements in the FDA guidance and confirming your facility has an established compliance profile and is not under OAI status. Next, prepare internally by assessing your quality system against the 11 MDDAP practice areas and identifying the champions who will lead the initiative inside your organization. Then engage with MDIC to understand the community and access resources, and work with ISACA or PRI to schedule your baseline appraisal.

The honest first question is whether your underlying system is ready to be measured. If you are not yet certified, or your ISO 13485 system is more aspiration than operation, the highest-value move is to build that foundation first — then appraise. That is the work MSI does every day. For leaders still weighing whether and when to pursue device certification, the ISO Executive Decision Briefs lay out the real cost, timeline, and business case in a short, leadership-level format before you commit a dollar of project budget.

FDA Voluntary Improvement Program: Frequently Asked Questions

Ask. Understand. Decide.

Is the FDA Voluntary Improvement Program mandatory?

How much does participation cost?

How long does an appraisal take?

Can international facilities participate?

What happens if we score low on the appraisal?

How does the program relate to the QMSR and ISO 13485?

Where the FDA Voluntary Improvement Program Is Headed

Expanding. Maturing. Converging.

With final FDA guidance in place and a second implementing partner added to expand appraisal capacity, the FDA Voluntary Improvement Program is built to grow rather than wind down. Industry watchers expect the program to keep evolving — broader eligibility over time, additional regulatory opportunities for high-performing participants, deeper benchmarking across the participant community, and tighter integration with the FDA's other quality initiatives. The arrival of the QMSR only accelerates that direction, because it gives every U.S. device manufacturer a regulatory reason to care about the same ISO 13485 maturity the program measures.

For manufacturers weighing whether to engage, the strategic read is straightforward. The regulatory environment is converging on ISO 13485 as the common language of device quality, and the FDA Voluntary Improvement Program is the FDA-supported mechanism for proving you speak it fluently. Getting in early — while the program is still differentiating its participants from the broader market — is a way to turn a quality system you already have to build into a visible competitive signal. The manufacturers who treat maturity as a strategy rather than a cost are the ones the program was designed to reward.

The Bottom Line on the FDA Voluntary Improvement Program

Beyond compliance. Toward excellence.

The FDA Voluntary Improvement Program represents a shift from reactive compliance to proactive quality management. By taking part, medical device manufacturers gain proven best practices, real regulatory efficiencies, and a supportive community focused on continuous improvement — and they do it on the same ISO 13485 foundation the QMSR now requires. The program demonstrates that quality and efficiency are complementary, not competing: organizations that build mature quality systems move faster, innovate more effectively, and serve patients better than those that treat quality as a compliance burden.

For forward-thinking device makers, the path is straightforward: build a genuine ISO 13485 system, run it with discipline, then use the FDA Voluntary Improvement Program to measure and sharpen its maturity. That is how a quality system stops being a binder on a shelf and becomes a competitive advantage your auditors, regulators, and customers can all see.