Guidance & Regulatory Information

The Office of Combination Products develops regulations and guidance for combination products, in collaboration with FDA’s medical product centers. The links at the left of this page provide more information about combination product regulations and guidance, and procedures that FDA follows for the intercenter review of products.

OCP is requesting applicants/sponsors to submit RFDs (requests for designation) and Pre-RFDs (pre-requests for designation) electronically. To do so, applicants/sponsors may send RFDs and Pre-RFDs to combination@fda.gov and identify the submission type (“RFD” or “Pre-RFD” as applicable) in the subject line of the email. If a sponsor makes a paper submission of an RFD pursuant to 21 CFR Part 3, or makes a paper submission of a Pre-RFD, OCP requests applicants/sponsors to also notify our mailbox at combination@fda.gov. Finally, in lieu of telephone inquiries, please send all other information requests to our mailbox at combination@fda.gov.