On May 15, 2018, FDA issued a proposed rule amending its regulations in 21 CFR Part 3 on the classification of products as biological products, devices, drugs, or combination products, and their assignment to the Agency Centers for premarket review and regulation. The purposes of the amendments are to clarify the procedures and harmonize the regulations with recent changes to the relevant statutes and FDA policies.
Product classification is already part of determining which Agency Center will have primary jurisdiction. The proposed rule would amend 21 CFR 3.3 to clarify that the procedures for product jurisdiction apply when the classification of a product is unclear or in dispute, where the current rule states that the procedure is for when the Agency Center with primary jurisdiction is unclear or in dispute.
Currently, if a sponsor disagrees with determination of product jurisdiction made by the Office of Combination Products, it can request reconsideration under section 3.8(c), and if it disagrees with that decision, it can make an additional supervisory appeal to the Office of Special Medical Programs under section 10.75. Because the initial determination is made after a thorough review, and the reconsideration process does not allow for new information to be presented, the determination is unlikely to change under this process. If finalized, the proposed rule would remove the request for reconsideration step and allow sponsors to directly appeal a decision on jurisdiction.
In harmonizing the regulation with relevant statutes, the proposed rule would modify 21 CFR 3.4 to align with 21 USC 353(g) and specify that FDA will assign a combination product to the Center that regulates the constituent part providing the primary mode of action. The definition of “biological product mode of action” in 21 CFR 3.2 would be amended to align with the definition of “biological product” in 42 USC 262(i) and specify that proteins (except chemically synthesized polypeptides) are classified as biological products. The proposed rule would also exclude advisory content, providing such content instead in FDA guidance documents, such as “How to Write a Request for Designation (RFD).”