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Compliance Considerations for Combination Products (Drug-Device/Biologic-Device)

Updated: Feb 15


Combination products, such as drug-device and biologic-device combinations, offer innovative solutions in the pharmaceutical, biotechnology, and medical device industries. These products combine the therapeutic benefits of drugs or biologics with the advanced functionalities of medical devices. However, developing and commercializing combination products require careful consideration of regulatory requirements and compliance with specific standards. This article provides a detailed overview of compliance considerations for combination products, offering valuable insights to ensure successful market access.

Combination products, such as drug-device and biologic-device combinations, offer innovative solutions in the pharmaceutical, biotechnology, and medical device industries. These products combine the therapeutic benefits of drugs or biologics with the advanced functionalities of medical devices. However, developing and commercializing combination products require careful consideration of regulatory requirements and compliance with specific standards. This article provides a detailed overview of compliance considerations for combination products, offering valuable insights to ensure successful market access.


Understanding Combination Products:

  • Definition and classification of combination products (drug-device and biologic-device).

  • Regulatory authorities responsible for oversight (e.g., FDA, EMA).

  • Key challenges and benefits associated with combination products.

Regulatory Landscape:


  • Overview of regulatory frameworks governing combination products (e.g., FDA's 21 CFR Part 3, EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)).

  • Classification of combination products and determination of the lead regulatory authority.

  • Considerations for jurisdictional requirements (e.g., US, EU, international markets).


Design Control:

  • Importance of integrating design control processes for both drug and device components.

  • Ensuring compatibility and functionality of drug and device components.

  • Documentation requirements for design verification, validation, and risk management.


Unique Regulatory Challenges:

  • Addressing challenges associated with different regulatory pathways for drugs, biologics, and devices.

  • Demonstrating safety and efficacy of combination products through appropriate testing and clinical data.

  • Addressing post-approval changes, including modifications to either the drug or device component.


Quality Management System (QMS):

  • Implementing an integrated QMS for combination products.

  • Harmonizing quality systems requirements for drugs and devices.

  • Managing supplier qualification and control for components.


Risk Management:

  • Conducting risk assessments for combination products.

  • Identifying and mitigating risks associated with drug-device interfaces and user interactions.

  • Incorporating human factors engineering principles into device design.


Labeling and Instructions for Use:

  • Developing clear and concise labeling and instructions for use.

  • Ensuring appropriate communication of drug and device information to end-users.

  • Complying with requirements for labeling content, symbols, and warnings.


Post-Market Considerations:

  • Adverse event reporting and vigilance requirements.

  • Implementing effective post-market surveillance and complaint handling processes.

  • Post-approval changes and ensuring continued regulatory compliance.


Global Market Access:

  • Considerations for global market access, including variations in regional regulations.

  • Strategies for navigating international regulatory requirements and harmonization initiatives.

  • Collaboration with international regulatory authorities and Notified Bodies.


Developing and commercializing combination products require a comprehensive understanding of regulatory requirements and effective compliance strategies. Regulatory frameworks, design control, quality management systems, risk management, labeling, post-market considerations, and global market access are critical aspects to consider for successful market entry. By proactively addressing compliance considerations throughout the product lifecycle, manufacturers can ensure the safety, efficacy, and regulatory compliance of their combination products.


Please note that this article provides a general overview and should not be considered as legal or regulatory advice. It is recommended to consult with regulatory experts and seek specific guidance for individual combination product development projects.


Contact  BioBoston Consulting today or visit our  website to learn more about how we can support your organization.

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