Comparison of Combination Product Regulations: Challenges and approval pathway in the US and Europe

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This review compares regulatory challenges for combination products in US and EU, highlighting approval pathways and obstacles.

The review highlights challenges in the regulatory pathway for combination products across the US and EU.
Unique systems in the US and EU impact approval pathways, especially regarding classification and regulatory channels.
The analysis reveals obstacles such as PMOA determination and Notified Body capacity affecting product development.
Future regulatory development should address harmonization and integration of digital health in combination products.

Kalluri et al. (2025) studied this question.

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