Combination Products 2.0: Applying The New FDA Regulations

By Steven Richter, Ph.D

Combination products, those that contain medical devices embedded with pharmaceutical or biologic components, have become a large and growing segment of the medical device market. Some analysts estimate they represent over 30% of all new product submissions to the FDA.

Over the last 10 years, FDA regulatory centers have struggled with the changes and challenges that these new technologies present. For manufacturers too, the convergence of drugs/biologics and devices has created a host of regulatory issues, along with many exciting opportunities.

The FDA issued an informational compliance document in 2004. This didn't provide much guidance for practitioners in terms of regulatory methodology and lacked information on what parts of the USP and ISO documents would be required for combination products. In 2007, our first paper on the subject, "Combination Products: Navigating Two FDA Quality Systems," addressed these difficulties.