Compliance Considerations for Combination Products: Navigating Regulations and Standards

Explore essential compliance considerations for drug-device and biologic-device combination products. Learn about regulatory frameworks, quality management, risk assessment, and global market access strategies.

Drug-device and biologic-device combinations are some types of the combination products, and these provide ground-breaking inventions in the pharmaceutical, biotechnology, and medical device fields. They take the therapeutic effects of drugs or biologics and they blend it with the smart capabilities of a medical device. Yet, the combination of both products and bringing such to market call for a study on regulations as well as aligning with certain standards. In this article on compliance considerations for combination products, we give you an in-depth overview to help you formulate your strategy for market access. 

Comprehending Combination Products Our post entitled “Combination Product Basics” currently in publication on LinkedIn. 

A strong step forward in the definition and classification of combination products (drug-device, biologic-device) 

Entities engaged in oversight (e.g., FDA, EMA) 

The challenges and benefits of combination products are. 

Regulatory Landscape: 

Regulatory regime addressing combination products include 21 CFR Part 3, Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) and EU Regulations etc. 

Type of combination products and lead regulatory agency 

Jurisdictional requirements (US, EU, International markets) 

Design Control: 

The value of combo product design control processes:Testing and evaluating drug and device components for compatibility and functionality. 

Design verification, validation and risk documentation categories 

Unique Regulatory Challenges: 

Overcoming Regulatory pathways for Drugs Biologics Devices 

General approach to adequacy of testing and clinical data demonstrating safety, effectiveness for combination products. 

Management of post-approval changes (to the drug component, to the device component). 

Excellence-Inspiring Software: Quality Management System (QMS) 

Implementing an Integrated QMS for Combination Products 

Quality Systems Requirements for Drugs and Devices Harmonization 

Provider Approvals and Inspection of Items 

Risk Management includes: 

Assessment of Risk: Combination Products 

Risk identification and management for drug-device interfaces and usability 

Human factors engineering in device design 

Labels and Instructions for Use 

Clear and brief labeling with instructions for use. 

Correct communication of information regarding drug/device to the patient. 

Adherence To Labeling of Content, Symbols & Warnings 

Post-Market Considerations includes: 

Requirements related to Adverse event reporting and vigilance 

Creating a robust post-market surveillance and complaint handling infrastructure. 

Changes after approval and maintenance of authorization. 

Global Market Access: 

Global market access – regional regulation variances 

How international regulations and harmonization initiatives help product developers to bring these drugs to market 

Cooperation with foreign regulatory authorities and notified bodies. 

Conclusion:

Development and marketing of combination products involve thorough understanding of regulatory needs. Hence, proper compliance plans are indispensable. Regulatory frameworks, design control & quality management systems, risk management and post-market considerations are just a few of the important elements that must be complied with to enter the market. By taking a proactive approach to compliance considerations across the product lifecycle, manufacturers can better ensure that their combination products are safe, effective, and in compliance with regulations. 

Note: this article is intended as general information and not legal/regulatory advice. Consult with regulatory experts and obtain guidance for any given combination product development project. 

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