FDA Announces Third Year of Voluntary Quality Management Maturity (QMM) Prototype Assessment Program

On February 11, 2026, the U.S. Food and Drug Administration (FDA or the Agency) published a Federal Register notice announcing an opportunity for nine drug manufacturing establishments to participate in the third year of its Voluntary Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program (the Program).¹

Background

The Program is administered by FDA’s Center for Drug Evaluation and Research (CDER) and is open to manufacturers of CDER regulated drug products on a voluntary basis. The QMM Program is designed to “encourage drug manufacturers to implement quality management practices that go beyond current good manufacturing practice (CGMP) requirements.”² The Program utilizes a CDER-developed protocol assessment tool that evaluates how effectively drug manufacturers monitor and manage quality and quality systems.

The QMM Program is a spin-off of FDA’s Quality Metrics Program, which was proposed shortly after passage of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA). FDA relied on FDASIA’s grant of authority to the agency to collect certain records in advance of or in lieu of inspections when the Agency proposed guidance for industry that would have required manufacturers to provide FDA with certain manufacturing metrics. Stakeholders strongly opposed the quality metrics program,³ and in response, FDA amended the guidance, shifting to a scaled-back voluntary program. In 2018, the Agency announced two pilot Quality Metrics programs, the Quality Metrics Site Visit Program⁴ and a Quality Metrics Feedback Program ⁵, “for any establishment that had a quality metrics program developed and implemented by the quality unit and used to support product and process quality improvement.”⁶ Finally, in March 2022, FDA solicited comments to change the previously proposed Quality Metrics Reporting Program, which ultimately evolved into the QMM program that FDA launched in 2024. In 2024, the Program’s first year, the Program evaluated nine establishments.

CY 2026 QMM Prototype Assessment Protocol Evaluation Program

Now, in the Program’s third year, FDA streamlined the QMM assessment tool with a clearer, more concise rubric, using lessons learned from the 2024 Program. The tool continues to distinguish differences in maturity levels between practice areas at a single establishment, and continues to distinguish between maturity levels between establishments.

To participate in the program, the establishment must have the following characteristics:

• The potential participant is an establishment as defined in 21 CFR 207.1 that registers with FDA under section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and manufactures, prepares, propagates, compounds, or processes drugs, or active pharmaceutical ingredients (APIs) used in such drugs, subject to approval or licensure under section 505 of the FD&C Act or section 351 of the Public Health Service Act, or that are marketed pursuant to section 505G of the FD&C Act without an approved application under section 505 of the FD&C Act (often referred to as over-the-counter (OTC) monograph drug products).
• The establishment received at least one human drug surveillance inspection.
• The current inspection classification for the establishment at the time of the request to participate is No Action Indicated (NAI) or Voluntary Action Indicated (VAI).
• The establishment manufactures, prepares, propagates, compounds, or processes at least one CDER-regulated drug (API or finished drug product) that is currently in commercial distribution in the U.S.
• The establishment is willing to participate in an on-site or hybrid assessment.⁷

The Agency will choose 9 volunteer establishments for the program and will notify establishments of its decision within 60 days of receipt of their request to participate. Once selected establishments confirm their willingness to participate, the assessment will be conducted by three assessors following a pre-assessment questionnaire. The assessment team will only include CDER staff and will not include FDA staff from the Office of Inspections and Investigations.

After the assessment, establishments will receive a QMM assessment report which scores the establishment on each practice area. The report will also highlight areas of strength and actionable opportunities for improvement. The establishment will be encouraged to select one opportunity for improvement, develop a plan to implement improvement(s), and share the improvement plan with CDER. CDER will meet with the establishment twice — at three months and six months after the assessment — to discuss the proposed plan and progress made toward the improvement goals. Additionally, CDER will solicit feedback from participating establishments to improve the QMM assessment tool and protocol.

To participate in the CY 2025 QMM Program, manufacturers must submit a request by April 13, 2026.

Key Takeaways

Although the Program does not impose new regulatory requirements, manufacturers should think carefully about whether to participate. On the one hand, voluntary cooperation with the agency in a setting in which the agency can provide guidance for improvement could be useful. On the other hand, companies should consider whether potential release of a negative assessment under the Freedom of Information Act could paint the company in an unrepresentative light or trigger more intensive FDA scrutiny.

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© Arnold & Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.