Combination Products in the USA

Recommendation

29-31 March 2023
Heidelberg, Germany

The Validation Manager in the Pharmaceutical Industry

Combination products in the US are separately regulated by the FDA. For this reason, there is also an independent Office of Combination Products (OCP) whose task it is, among other things, to act as an "intermediary" between the other "offices". These offices are the Center for Devices and Radiological Health (CDRH, responsible for medical devices), the Center for Biologic Evaluation and Research (CBER, responsible for certain biotechnological products) and the Center for Drug Evaluation and Research (CDER, responsible for classical medicines and some biotechnological products).

A separate website for combination products is available, which is very clearly structured. It contains the following subpages:

• Meetings, Conferences, Workshops
• Feedback on Combination Products
• Classification and Jurisdictional  
  
  and
  
• Guidance and Regulatory Information

The latter section "Guidance and Regulatory Information" is particularly interesting. In addition to legislation (e.g. cGMP rules on combination products), rules and regulations, you can also find "Guidance Documents" that provide further assistance.  The 19 Guidance Documents are divided into "Pre-Market", "Post-Market" and Jurisdictional and are continuously supplemented or updated, e.g. when a draft document is finalised. 

You can find these guidelines on the specific combination products guidance documents site.