CPC Provides Comments on FDA’s Draft Guidance for Demonstrating Reliability of Emergency-Use Injectors

On June 22, 2020, the CPC filed comments on FDA’s “Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA: Draft Guidance for Industry and FDA Staff.” While we appreciate FDA’s efforts in providing needed guidance on this topic, we believe many of the recommendations in the Draft Guidance will create inherent regulatory uncertainty (if requirements are strictly imposed in FDA NDA/BLA review correspondence late in development), and some recommendations do not appear to be practical. The comment letter offers 11 major comments, including requests for FDA to resolve uncertainty around (among other areas) the parameters to which the 99.999% reliability specification applies, the point at which the specified reliability must be met, and the devices that fall within the scope of the Draft Guidance.