As technology and science advance, the FDA expects to review a growing number of combination products—products that combine drugs, medical devices, and/or biologics.
Because combination products involve oversight by different types of regulatory authorities, the path to approval is complex and varied. To ensure your project has the quality systems to support all aspects of regulatory review and approval, partner with EMMA International.
Using our pharmaceuticals, biologic, and medical device expertise, EMMA International will put the systems in place to ensure compliant development structure and regulatory processes. We’ve prepared hundreds of 510(K), PMA, De Novo, IDE, EUAs, INDs, NDAs, ANDAs, and Breakthrough Device Designation submissions over the years, which means you’re assured to-the-letter accuracy and timeliness.
Combination Product Timeline
A pre-request for designation is the first step in your regulatory journey. EMMA International collaborates with the FDA’s Office of Combination Products (OCP) to classify your product. If you’re seeking European approval, we help develop a regulatory plan for EU MDR compliance.
From there, your combination product will follow a multilevel path that involves: