CPC Comments on FDA’s “Draft Guidance for Industry and Staff: Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development”

The CPC submitted comments on FDA’s Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development Draft Guidance.  CPC’s comments included, among others, the following recommendations:

• Resolve inconsistencies between the Draft Guidance and other FDA guidance documents
• Better define the relationship between HF testing and clinical studies
• Clarify expectations with respect to revalidation of post-HF validation changes
• Clarify when HF testing is required for combination products and the scope of such testing