How to authorize a Combination Product in the USA?

Recommendation

23-25 April 2024

Cleaning Validation AND Pre-Course Workshop: Impact of Annex 1 Revision on Cleaning Validation - Live Online Training

In the USA, combination products are regulated independently. Since combination products are made up of different components, several FDA Centers may be involved in the marketing authorisation process. A draft document from the FDA entitled "Principles of Premarket Pathways for Combination Products" describes the ways in which marketing authorisations are granted in the USA and how the various Centers interact.

The main constituent (Primary Mode of Action = PMOA) of the combination product is decisive for the Center that receives the "lead". For example, if it is the biological one, the CBER would "take the lead". Furthermore, the draft also describes general information on the authorisation of combination products; among others, the procedures relevant for medical devices, Premarket Approval (PMA), De Novo classification, and 510k procedures. In addition, authorisation procedures for medicinal products, such as New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) procedures and, for biological products the Biological License Application (BLA), are explained. 

Annex with illustrative examples

An annex shows possible authorisation pathways for combination products in which the medical device is the main constituent. In total, 5 examples (e.g. the introduction of a new drug effect) are used to illustrate possible pathways.

It is expressly pointed out that this draft only provides general information on the marketing authorisation of combination products and that further guidelines are available for the marketing authorisation of specific combination products.

Please also see the draft of the document entitled "Principles of Premarket Pathways for Combination Products - Guidance for Industry and FDA Staff".