--- title: "Combination Product, Definition | MedTech Terms" description: "Product comprised of two or more regulated components - e.g., drug-device, biologic-device. 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This determination guides which FDA center has primary jurisdiction for premarket review." } }, { "@type": "Question", "name": "Do combination products require multiple marketing authorizations?", "acceptedAnswer": { "@type": "Answer", "text": "Depending on the constituent parts and regulatory jurisdiction, a combination product may necessitate a single integrated marketing authorization application or separate applications that are cross-referenced." } }, { "@type": "Question", "name": "How does ISO 13485 apply to combination products?", "acceptedAnswer": { "@type": "Answer", "text": "ISO 13485, the standard for medical device quality management systems, is typically applied to the device constituent part, while drug constituent parts would follow appropriate pharmaceutical GMPs. The overall QMS needs to integrate both." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. Combination Product [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways) # Combination Product Product comprised of two or more regulated components - e.g., drug-device, biologic-device. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Per 21 CFR 3.2(e), a combination product is composed of two or more different types of medical products (drug, device, biologic) that are physically, chemically, or otherwise combined or co-packaged. What the regulation says The FDA defines combination products in 21 CFR 3.2(e) and specifies streamlined current Good Manufacturing Practice (cGMP) requirements in 21 CFR Part 4, ensuring compliance for products combining drugs, devices, and/or biological products. The EU [MDR](/terms/mdr-reporting) (Regulation (EU) 2017/745) also addresses products incorporating medical devices and medicinal substances, often requiring consultation with a medicines authority for classification and regulatory oversight. ## What this means in practice FDA assigns a lead center based on the product's primary mode of action. Combination products must comply with both drug GMPs and device QSR/ [QMSR](/terms/qmsr) via streamlined cGMP requirements at 21 CFR Part 4. ## Examples - A pre-filled syringe combining a drug and a delivery device is a common combination product. - Drug-eluting stents, which release medication to prevent restenosis, are another example of a combination product. - Insulin pens, which integrate a drug-delivery system with insulin, exemplify a drug-device combination. Common pitfalls - • Failing to identify a product as a combination product early in development can lead to significant regulatory delays. - • Incorrectly determining the primary mode of action may result in submission to the wrong lead center, causing rework. - • Assuming that only one set of GMPs applies can result in non-compliance with applicable regulations for both components. - • Overlooking the need for a comprehensive quality management system that integrates requirements for all constituent parts is a common pitfall. - • Underestimating the complexity of post-market surveillance and reporting for combination products can lead to compliance issues. ## Frequently asked questions What is the primary mode of action (PMOA)? The PMOA is the single mode of action of a combination product that provides the most important therapeutic action of the combination product. This determination guides which FDA center has primary jurisdiction for premarket review. Do combination products require multiple marketing authorizations? How does ISO 13485 apply to combination products? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory Request for Designation(RFD) Formal mechanism to obtain a binding FDA decision on which Center will regulate a product. ](/terms/rfd)[ Quality & Risk Quality Management System Regulation(QMSR) FDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference. ](/terms/qmsr)[ Quality & Risk Quality System Regulation(QSR / 21 CFR 820) FDA's current good manufacturing practice (cGMP) requirements for medical devices. ](/terms/qsr) ### De Novo & Breakthrough Pathways · From this learning path [ Regulatory Premarket Approval(PMA) FDA's most stringent device marketing application, required for high-risk Class III devices. Adjacent lesson ](/terms/pma?from=de-novo-and-breakthrough)[ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k?from=de-novo-and-breakthrough)[ Regulatory Breakthrough Device Designation(BDD) FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions. ](/terms/breakthrough-device?from=de-novo-and-breakthrough)[ Regulatory De Novo Classification Request(De Novo) Pathway to classify novel low- to moderate-risk devices that lack a predicate. ](/terms/de-novo?from=de-novo-and-breakthrough) ### More in Regulatory · Same category [ Regulatory Indications for Use(IFU (statement)) Description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate. ](/terms/indications-for-use) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [De Novo & Breakthrough Pathways](/paths/de-novo-and-breakthrough)Lesson 11 of 11 Ecosystems (1) - [Regulated Pathways](/ecosystems/regulated-pathways) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 1 eCFR· 1 European Commission· 1 1. [1 Combination Products Verified FDA · fda.gov ](https://www.fda.gov/combination-products) 2. [2 21 CFR Part 4 Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-4) 3. [3 European Commission - Medical Devices Verified European Commission · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector_en) 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 Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=combination-product) Learn in 60 seconds Card Lesson Quiz Product comprised of two or more regulated components - e.g., drug-device, biologic-device. - · FDA assigns a lead center based on the product's primary mode of action. - · Combination products must comply with both drug GMPs and device QSR/QMSR via streamlined cGMP requirements at 21 CFR Part 4. Remember this Watch out: Failing to identify a product as a combination product early in development can lead to significant regulatory delays. Related terms - [Quality System Regulation(QSR / 21 CFR 820) ](/terms/qsr) - [Quality Management System Regulation(QMSR) ](/terms/qmsr) - [Request for Designation(RFD) ](/terms/rfd) You may also need Auto-suggested from Regulatory and shared keywords. - [Additional Condition for Nonprescription Use(ACNU) ](/terms/acnu) - [High-Risk AI System (EU AI Act) ](/terms/ai-act-high-risk-system) - [340B Drug Pricing Program(340B) ](/terms/340b) - [Drug Delivery Devices ](/terms/drug-delivery-devices) - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [Device Master File(MAF) ](/terms/device-master-file) [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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