The FDA issued a draft guidance on the preliminary request for designation process and what information to include. The pre-RFD process provides feedback on the regulatory identity or classification of a drug, biologic, or combination product, which could include a medical device.
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.
A pre-RFD application must include a listing of all components and ingredients, as well as instructions for the product’s use.
Applications can be submitted to the FDA’s Office of Combination Products, which will conduct a preliminary assessment for the application’s completeness within five business days and alert the sponsor before beginning the full review.
If approved, the office will issue an initial classification, saying whether CBER, CDER or CDRH will regulate the product or hold primary jurisdiction.