CPC Comments on FDA’s Draft Guidance Entitled “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA”

While the CPC agrees with many of the recommendations in the Draft Guidance, we strongly recommend that FDA revise the document to: (1) improve alignment between the Draft Guidance and existing human factors (“HF”) guidance provided by FDA and by recognized U.S. and international standards; (2) focus comparative analyses on risk, not use error rates; (3) describe HF studies as qualitative research (to assess the adequacy of the product user interface) rather than quantitative research (to assess the capabilities of the users); (4) promote innovation and improvements to the design of products to enhance safety and effectiveness; and (5) provide more information regarding topics not sufficiently addressed in the Draft Guidance.