The US Food and Drug Administration published the revised final guidance Application User Fees for Combination Products yesterday (16 July, 2024). This guidance replaces the final guidance issued in 2005.
Combination products are comprised of two or more different types of products (i.e., a combination of a drug, device, and/or biological product with one another).
Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products.
The drugs, devices, and biological products included in combination products are referred to as constituent parts of the combination product.
Single-entity combination products: These include products like pre-filled syringes and transdermal patches.
Co-packaged combination products: These involve two or more separate products packaged together, such as a drug and device kit.
Cross-labeled combination products: These include products that are marketed separately but intended for use together, such as a biologic and a specific device.
Drug-drug products, device-device products, or products that consist solely of more than one biological product do not meet the definition of a combination product and are outside the scope of this guidance.
The guidance explains that combination products for which a single application is submitted should be assessed the applicable user fee associated with that particular type of application. As part of the guidance, users will also be able to find out how user fees are applied for combination products when separate applications are submitted for each constituent part.
If the applicant chooses to submit two applications for a cross-labeled combination product, each would be assessed the applicable user fee for each application. When FDA determines that a single application is not appropriate and separate applications are necessary, the guidance describes how a certain waiver provision under the Prescription Drug User Fee Act (PDUFA) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) could reduce the total application fee amount.
For more detailed information, refer to the USFDA Guidance on Application User Fees for Combination Products.
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