FDA’s new draft guidance could hinder applications for digital combination products

The FDA released new draft guidance yesterday regarding premarket review for combination products — those with a mix of components that span across the agency’s drug, biologic and device product categories.

The proposed premarket guidance, which may still be adjusted based on public feedback, broadly advises industry to submit a single regulatory application within the pathway that most closely aligns with that product’s “primary mode of action,” as opposed to submitting multiple types of applications. The draft also includes suggestions and examples of which kinds of products would be most appropriate for each regulatory center.

“Today, as part of several steps we’re taking in...