CPC Comments on FDA’s Multiple Function Device Products Draft Guidance
Among other comments, we recommend that FDA: (i) clarify how the Draft Guidance applies to drug- and biologic-led combination products, (ii) provide additional information regarding how the multiple function exclusion to the device definition will be implemented, and (iii) clarify that potential new risks (in addition to increased risks) should be part of the risk assessment of the combination of the device function and the non-device function.