USA – Combo Product Reviews: FDA Drafts Guidance

The US Food and Drug Administration (FDA) on Tuesday released high-level draft guidance explaining the principles for premarket review of combination products, including how sponsors can determine which type of premarket submission is appropriate.

The 22-page draft, which implements a section of the 21st Century Cures Act, explains what combination products are, how their various FDA center assignments are determined and considerations for making approval pathway determinations.

FDA’s current thinking is that a single application is generally appropriate for a combination product, the guidance notes, with the primary mode of action (PMOA) determining which type of marketing application should be submitted (e.g., a PMA, De Novo, or 510(k) for a device-led combination product, an NDA or ANDA for a drug-led combination product or a BLA for a biologic-led combination product).

FDA also notes that the premarket review of a combination product can be “significantly streamlined” when its sponsor is legally authorized to rely on FDA’s prior findings of safety or effectiveness or substantial equivalence with respect to an approved or cleared constituent part, or where the sponsor has a right of reference for another sponsor’s data…