OPERON ELEVATEPLUS | DRUG-DEVICE COMBINATION PRODUCTS DOCUMENTATION
Drug-Device Combination Products – Regulatory & Development Consulting
Operon Strategist helps US manufacturers navigate the regulatory complexity of drug-device combination products from Primary Mode of Action (PMOA) determination and FDA 21 CFR Part 4 applicability to design control, risk management, and submission-ready technical documentation.
Our team supports companies bringing combination products to the US market, aligning device (21 CFR Part 820/QMSR) and drug/biologic requirements into a single, coherent regulatory strategy so you avoid duplicated effort, submission delays, and FDA information requests.
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Operon ElevatePlus
Drug-Device Combination Products Documentation Service Portfolio
Regulatory Strategy & Product Classification
Determine drug-device combination product classification and regulatory applicability
Identify applicable regulatory pathways under FDA 21 CFR Part 4, 21 CFR Part 820/QMSR, EU MDR 2017/745, ISO 13485, ISO 14971 & ICH guidelines
Assess Primary Mode of Action (PMOA) and lead regulatory authority
Develop market-specific regulatory and approval strategy roadmap
Design & Development Documentation
Design planning, user needs, design inputs & outputs documentation
Design transfer, change control, Structured Design History File (DHF) & Device Master Record (DMR) documentation
Design verification, validation & design review documentation support
Technical File, Design Dossier & Product Specifications File preparation for global compliance
Risk Management & Quality Systems
ISO 14971-compliant Risk Management File, hazard identification & risk analysis
Use-related risk analysis, FMEA/dFMEA/pFMEA & Fault Tree Analysis (FTA)
Benefit-risk evaluation, risk control, residual risk & post-production risk review
IEC 62366-1 usability engineering, human factors & formative/summative studies
GSPR & Essential Requirements Compliance
EU MDR Annex I General Safety & Performance Requirements (GSPR) checklist preparation
Mapping of applicable standards, testing evidence & compliance documentation
Essential Requirements Checklist support for legacy MDD products
GSPR compliance review aligned with EU MDR technical documentation requirements
Technical Documentation & Validation Support
Product description, intended use, formulation & device specification documentation
Clinical evaluation, clinical evidence, performance testing & software documentation
Biocompatibility, sterilization, packaging & shelf-life validation documentation
Labeling, IFU, CAPA, complaint handling, PMS & PMCF documentation support
Article 117 of EU MDR 2017/745 amends Directive 2001/83/EC & Notified Body Opinion (NBOp) Support
Article 117 of EU MDR 2017/745 amends Directive 2001/83/EC applicability assessment for medicinal products with device components
Technical documentation, GSPR, risk management & usability evidence compilation
Coordination with Notified Bodies (NB) and deficiency response support
Support for NB review of design, clinical, IFU, sterility & packaging validation documentation
What Sets Us Apart
Global exposure, structured thinking, and execution-ready expertise
Extensive Experience Across Drug, Device & Combination Product Regulations
Expertise in FDA 21 CFR Part 4, 21 CFR Part 820, ISO 13485, & EU MDR Requirements
Global Consulting Support from Concept Development to Regulatory Submission
Proven Capability in Risk Management, CAPA, DHF & Audit Readiness
Regulatory and documentation support for drug–device combination products – we support manufacturers in navigating complex regulatory pathways through integrated strategy and documentation development. Our services include product classification, regulatory pathway assessment, design and risk documentation, and implementation of CAPA and quality systems. This structured approach reduces regulatory risk, strengthens audit readiness, and enables timely progression toward market approval.
Operon Drug-Device Combination Products Documentation Advantage
Expert regulatory strategy, design control, and compliance support for drug-device combination products under global regulatory frameworks such as FDA and EU MDR
End-to-End Regulatory Consulting for Drug-Device Combination Products
Integrated Approach Covering Both Drug & Device Compliance Requirements
Strong Alignment with Quality Management & Design Control Systems
Audit-Ready Documentation & Regulatory Submission Support
frequently asked questions
What is a drug-device combination product?
A drug-device combination product combines a drug and a medical device (or biologic and device) into a single product, such as a prefilled autoinjector, drug-eluting stent, or inhaler with metered dosing. In the US, FDA regulates these under 21 CFR Part 3 and Part 4.
Which FDA center regulates my combination product?
FDA assigns a lead center — CDER, CBER, or CDRH — based on the product’s Primary Mode of Action (PMOA), the therapeutic action that provides the most important effect. Operon Strategist helps determine PMOA and the correct regulatory pathway early in development.
What documentation is required for FDA submission of a combination product?
Typical documentation includes design control records (DHF/DMR), risk management files per ISO 14971, human factors validation, biocompatibility and stability data, labeling/IFU, and cGMP compliance evidence under 21 CFR Part 4, in addition to the primary drug or device application (NDA, BLA, 510(k), or PMA).
How long does it take to prepare combination product documentation?
Timelines vary based on product complexity, existing design records, and regulatory pathway, but structured documentation development typically takes several weeks to a few months. Early engagement significantly reduces the risk of FDA deficiencies and review delays.
Planning a Drug-Device Combination Product Approval
Talk to a combination product expert