--- title: "MDUFA, Medical Device User Fee Amendments | MedTech Terms" description: "Statutory framework setting FDA device user fees and corresponding performance commitments, reauthorized every five years." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/mdufa#term", "name": "Medical Device User Fee Amendments", "alternateName": "MDUFA", "description": "MDUFA (currently MDUFA V, FY2023–2027) ties industry-paid user fees to FDA performance goals on review timelines, total time to decision, and program improvements such as the Q-Sub program and Total Product Lifecycle Advisory Program.", "url": "https://medtechterms.com/terms/mdufa", "termCode": "mdufa", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/mdufa#article", "headline": "MDUFA, Medical Device User Fee Amendments", "description": "Statutory framework setting FDA device user fees and corresponding performance commitments, reauthorized every five years.", "url": "https://medtechterms.com/terms/mdufa", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/mdufa" }, "about": { "@id": "https://medtechterms.com/terms/mdufa#term" }, "articleSection": "Regulatory", "inLanguage": "en", "keywords": "Medical Device User Fee Amendments, MDUFA, Regulatory, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-05-05", "dateModified": "2026-05-05", "citation": [ { "@type": "CreativeWork", "name": "FDA MDUFA", "url": "https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "European Commission - Medical Devices", "url": "https://health.ec.europa.eu/medical-devices-sector_en", "publisher": { "@type": "Organization", "name": "European Commission" } }, { "@type": "CreativeWork", "name": "IMDRF Documents", "url": "https://www.imdrf.org/documents", "publisher": { "@type": "Organization", "name": "IMDRF" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/q-sub#term", "name": "Q-Submission (Pre-Submission)", "alternateName": "Q-Sub / Pre-Sub", "url": "https://medtechterms.com/terms/q-sub" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/510k#term", "name": "510(k) Premarket Notification", "alternateName": "510(k)", "url": "https://medtechterms.com/terms/510k" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/pma#term", "name": "Premarket Approval", "alternateName": "PMA", "url": "https://medtechterms.com/terms/pma" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Regulatory", "item": "https://medtechterms.com/terms?cat=Regulatory" }, { "@type": "ListItem", "position": 4, "name": "Medical Device User Fee Amendments", "item": "https://medtechterms.com/terms/mdufa" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/mdufa#faq", "mainEntity": [ { "@type": "Question", "name": "What is the primary purpose of MDUFA?", "acceptedAnswer": { "@type": "Answer", "text": "The primary purpose of MDUFA is to provide the FDA with additional resources for the review of medical device applications, in exchange for which the agency commits to specific performance goals and review timelines." } }, { "@type": "Question", "name": "How does MDUFA affect medical device manufacturers?", "acceptedAnswer": { "@type": "Answer", "text": "MDUFA directly affects manufacturers through the user fees paid for submitting devices for FDA review, and indirectly through the FDA's enhanced capacity and predictability in the review process, which can influence market access timelines." } }, { "@type": "Question", "name": "What are some key improvements influenced by MDUFA?", "acceptedAnswer": { "@type": "Answer", "text": "MDUFA has influenced improvements such as the Q-Submission program, which allows manufacturers to get early feedback from the FDA, and initiatives aimed at IT modernization and enhanced review predictability." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. Medical Device User Fee Amendments [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)MDUFA # Medical Device User Fee Amendments Statutory framework setting FDA device user fees and corresponding performance commitments, reauthorized every five years. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition MDUFA (currently MDUFA V, FY2023–2027) ties industry-paid user fees to FDA performance goals on review timelines, total time to decision, and program improvements such as the [Q-Sub](/terms/pre-submission) program and [Total Product Lifecycle](/terms/tplc) Advisory Program. What the regulation says The Medical Device User Fee Amendments (MDUFA) program, authorized by Congress and renewed periodically, allows the FDA to collect fees from medical device companies. In exchange for these fees, the FDA commits to meeting specific performance goals related to the review of medical device submissions, as outlined in the commitment letter negotiated with industry, for example, MDUFA V for fiscal years 2023-2027. ## What this means in practice MDUFA negotiations heavily shape FDA hiring, IT modernization, and review predictability - the biggest practical driver of CDRH responsiveness. ## Examples - A manufacturer planning a novel device submission considers the established MDUFA V review targets for Premarket Approval (PMA) applications when setting their project timeline. - During MDUFA negotiations, industry representatives advocate for clearer performance metrics for 510(k) reviews to improve predictability for new medical devices. - An emerging MedTech company budgets for MDUFA user fees as a mandatory expense before submitting its device for FDA clearance or approval. Common pitfalls - • Failing to account for MDUFA-driven FDA priorities can lead to misaligned submission strategies. - • Assuming MDUFA performance goals guarantee individual submission timelines is a common but incorrect expectation. - • Ignoring the impact of MDUFA negotiations on FDA resource allocation can result in an incomplete understanding of review processes. - • Overlooking the continuous evolution of MDUFA commitments can lead to outdated regulatory planning. - • Misinterpreting MDUFA as solely a funding mechanism, rather than a performance agreement, undervalues its regulatory impact. ## Frequently asked questions What is the primary purpose of MDUFA? The primary purpose of MDUFA is to provide the FDA with additional resources for the review of medical device applications, in exchange for which the agency commits to specific performance goals and review timelines. How does MDUFA affect medical device manufacturers? What are some key improvements influenced by MDUFA? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory Premarket Approval(PMA) FDA's most stringent device marketing application, required for high-risk Class III devices. ](/terms/pma)[ Regulatory Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub) Voluntary mechanism to obtain FDA feedback before a formal premarket submission. ](/terms/q-sub) ### More in Regulatory · Same category [ Regulatory 510(k) Summary vs 510(k) Statement Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request. ](/terms/510k-summary-vs-statement)[ Regulatory 513(g) Request for Information(513(g)) Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k)[ Regulatory Accreditation Scheme for Conformity Assessment(ASCA) FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny. ](/terms/asca) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 1 European Commission· 1 IMDRF· 1 1. [1 FDA MDUFA Verified FDA · fda.gov ](https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa) 2. [2 European Commission - Medical Devices Verified European Commission · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector_en) 3. [3 IMDRF Documents Verified IMDRF · imdrf.org ](https://www.imdrf.org/documents) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Acronym MDUFA Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=mdufa) Learn in 60 seconds Card Lesson Quiz Statutory framework setting FDA device user fees and corresponding performance commitments, reauthorized every five years. - · MDUFA negotiations heavily shape FDA hiring, IT modernization, and review predictability - the biggest practical driver of CDRH responsiveness. Remember this Watch out: Failing to account for MDUFA-driven FDA priorities can lead to misaligned submission strategies. Related terms - [Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub) ](/terms/q-sub) - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [Premarket Approval(PMA) ](/terms/pma) You may also need Auto-suggested from Regulatory and shared keywords. - [Safer Technologies Program(STeP) ](/terms/step) - [Real-Time PMA Supplement Review ](/terms/pma-real-time-review) - [Healthcare and Public Health Cybersecurity Performance Goals(HPH-CPG) ](/terms/hph-cpg) - [Total Product Lifecycle(TPLC) ](/terms/tplc) - [Breakthrough Device Designation(BDD) ](/terms/breakthrough-device) - [Refuse to Accept(RTA) ](/terms/rta) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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