REGULATORY AND QUALITY

Donawa Lifescience is your ideal partner to help achieve your US and EU combination product project goals. Donawa has long-standing experience in helping companies plan their drug-device project launches, based upon a clear understanding of EU/US drug-device combination product requirements. These projects have covered a wide range of products, including inhalation and diagnostic products, bone fillers, novel drug delivery devices, and more.

Combination products consist of drugs, devices and/or biological products combined in specific configurations. They may be physically or chemically combined, they may be packaged with one another, or they may be separately distributed with labeling that indicates their combined use.

The primary US regulation on combination products is in 21 CFR Part 3, ‘Product Jurisdiction’. This regulation specifies how FDA will determine which of its agency components (e.g., Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), or the Center for Drug Evaluation and Research (CDER)) will have primary jurisdiction for the premarket review and regulation of combination products. FDA makes this determination based upon the Primary Mode of Action (PMOA) of the product. In some cases, however, the PMOA is not clear and a Request for Designation may need to be submitted to FDA. In other cases, the Office of Combination Products may provide assistance; however, this office is not responsible for conducting any part of the regulatory review that will be required for placing the product on the US market.

Once it is determined which FDA agency component will have primary jurisdiction, it will be necessary to comply with all relevant data requirements for the submission, conduct any required clinical studies, be aware of quality system / GMP issues that will need to be addressed, and plan for the requirements that will need to be met after the product has been placed on the US market.

There are important differences between European and US requirements for drug-device combination products and drug delivery devices. These differences can sometimes represent significant difficulties in achieving market access when they are not understood early enough in the project management process. Donawa has the knowledge and experience to assist in the development of effective regulatory, clinical study, and quality system strategies for these types of product so that important project milestones can be met.

Donawa is a well-respected resource in the area of EU and US quality management system compliance, performing on-site quality system gap analyses and audits for compliance with European and US requirements for combination products.

Donawa can provide the support you need to understand and properly interpret US regulatory and clinical data requirements for combination products, including any ‘grey’ areas, together with anticipating FDA expectations, all of which is fundamental for successful marketing clearance of combination products destined for the US. Donawa’s recognized expertise in US medical device quality system implementation and compliance means we can also help to address the quality system requirements in 21 CFR Part 3 for these types of projects, including taking account of the FDA’s January 2015 guidance ‘Current Good Manufacturing Practice Requirements for Combination Products’ and more recent updates.

Donawa can help with all phases of understanding and compliance with US combination product requirements, including obtaining FDA feedback on planned project activities, clarifying regulatory and data requirements, conducting clinical studies, and complying with quality system and/or GMP requirements.