Requests for Comment

The Office of Combination Products (OCP) is working to clarify a variety of issues related to combination product regulation. Two such areas concern (1) how post-market adverse event reporting should be most appropriately handled for combination products, and (2) determining the appropriate number of marketing applications that should be submitted for a combination product.

 

OCP is seeking comments and thoughts from the public as it begins to develop policies on these two issues. In order to stimulate public input, OCP is posting two documents that describe some initial thoughts on these issues. These concept papers are provided for public comment purposes only. OCP welcomes comments from interested stakeholders on the general direction outlined, on alternative approaches that you believe FDA should consider, on the mechanisms you believe are needed for implementation (e.g., guidance, regulation), and on any other issues that you believe should be addressed in future guidance and/or regulations on these issues. In the interim, FDA encourages applicants who are uncertain about how these issues should be handled for their particular combination product to discuss the issue with OCP.

 

Please direct any comments or questions to the attention of Patricia Y. Love, MD, of OCP at combination@fda.gov, or at (301) 796-8930.