Guidance Describes Preliminary RFD Process for Combination Products

The FDA issued a draft guidance on the preliminary request for designation process, and what information to include. The pre-RFD process provides informal, non-binding feedback on the regulatory identity or classification of a drug, biologic or combination product.

The process has fewer requirements than the full RFD program, and can be helpful if a product is very early in its development, or if the product’s classification — or the agency center it would be assigned to — is unclear or in dispute.

The guidance recommends paying special attention to the product description, why it would be used, and how it works — and in the case of combination products, the relative contribution of each component. In addition, the sponsor should include any marketing claims planned for the product, and whether the combination product will be marketed as a whole or by its constituent parts.