Drug Device Combination Products
What Are Drug-Device Combination Products?
Drug-Device Combination Products are innovative healthcare solutions that integrate a medical device, drug, or biologic—or a mix of these elements—into a single product. According to the FDA and EU MDR regulations, these products are designed to improve patient outcomes by combining therapeutic and delivery functions.
Common examples include:
Drug-eluting stents (DES) – devices coated with drugs to prevent arterial blockage
Prefilled syringes, pens, and injectors
Drug-releasing implants
Dry powder inhalers
Cosmetic-drug hybrids (cosmeceuticals)
Such products require robust design and development documentation to meet regulatory expectations for safety, efficacy, and quality.
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FDA Guidance on Drug-Device Combination Products
The FDA Combination Products Guidance classifies these into three main categories:
Single-entity products (drug + device in one product, e.g., prefilled syringes)
Co-packaged products (drug and device packed together)
Cross-labeled products (drug and device separately manufactured but intended for combined use)
For regulatory compliance, manufacturers must align with:
21 CFR Part 4 (Combination Products)
21 CFR Part 820 (Medical Device QSR)
21 CFR 210/211 (Drug cGMP requirements)
ISO 13485:2016 (Medical Device QMS Standard)
Combination Products Development and Design Control
A strong design and development process is essential to ensure safety and performance. Manufacturers must establish:
Design History File (DHF) – Records design activities for audits
Device Master Record (DMR) – Extracted from DHF for routine use and tech transfer
Device History Record (DHR) – Documents compliance during routine production
Medical Device File (per ISO 13485:2016)
At Operon Strategist, we help manufacturers implement design control procedures that meet both FDA and EU MDR requirements. This ensures your product is ready for audits, inspections, and global registrations.
Drug-Device Combination Products and CE Marking (EU MDR)
Under EU MDR (2017/745, Articles 1(8) & 1(9)), integral combination products must demonstrate compliance with both device safety and drug efficacy. Examples include:
Pre-assembled syringes, injectors, and applicators
Drug-delivery implants
Dry powder inhalers
Electronic tablet dispensers
We assist with preparing the technical documentation and supporting regulatory submissions required for CE Mark approval.
CAPA Management for Combination Products
CAPA (Corrective and Preventive Action) is critical to maintaining compliance. For combination products, this includes:
Defining user needs and intended use
Establishing design input & output requirements
Performing design verification & validation
Ensuring change control during development and post-market stages
Maintaining a design history file for regulatory readiness
Operon Strategist helps manufacturers set up CAPA systems aligned with FDA and EU requirements to avoid 483 observations and compliance failures.
Why Choose Operon Strategist for Combination Products Consulting?
With extensive experience in drug, device, and biologics regulations, Operon Strategist supports companies in achieving compliance across multiple frameworks:
Drug GMP (21 CFR 210/211)
Medical Device QSR (21 CFR 820)
Combination Products (21 CFR Part 4)
ISO 13485 Quality Systems
Our Services Include:
Regulatory pathway assessment for FDA & CE Marking
Support for audit readiness & CAPA implementation
End-to-end consulting from concept to post-market surveillance
With Operon Strategist, you gain a trusted regulatory partner who ensures your Drug-Device Combination Products meet global standards, reduce compliance risks, and accelerate market entry.
FAQ'S
Drug-device combination products are therapeutic or diagnostic products that integrate a medical device with a drug or biologic. These products require compliance with both drug and device regulatory frameworks.
Because they involve both drug and device components, manufacturers must meet dual regulatory requirements. This includes proving product safety, quality, efficacy, and compatibility of both components.
We help manufacturers with product classification, preparing technical and design documentation, managing risk assessments, and navigating complex regulatory submissions to ensure timely approval.
Required documentation typically includes design and development files, risk management reports, clinical evaluation data, labeling, and manufacturing process records.
Yes. Operon Strategist provides global regulatory consulting, helping companies comply with requirements in regions like the EU, US, and other major markets.