Combination Products 3.0: Applying the 2013 FDA Regulations

A white paper by Steven G. Richter, Ph.D. of Accuratus Lab Services.

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. Over the last 10 years, FDA regulatory centers and manufacturers have struggled with the changes and challenges that these new technologies present. The FDA issued an informational compliance document in 2004 that provided little guidance in terms of regulatory methodology and lacked information on the USP and ISO documents that would be required for combination products. To add complexity, human tissue and cellular products are being incorporated in combination products, raising new challenges for testing, sterilization, and contamination avoidance.

Recently, the FDA issued streamlined regulations for Good Manufacturing Compliance (GMP) for combination products. This paper reviews those guidelines and provides insight into the testing requirements that will ensure GMP compliance.