FDA Guidance Sheds Light On Human Factor Studies For Combo Products

Questions from companies and FDA reviewers about human factor design and data requirements for combination products continue to grow. In response, the agency has issued a draft guidance.

FDA says most combination products only require a simulated-use human factors study, but some higher-risk products may require actual-use studies that include patient feedback to help the agency understand how the product fares in real-world settings.

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