FDA Releases Draft Guidance on Essential Drug Delivery Outputs By Adrienne R. Lenz, Principal Medical Device Regulation Expert —

https://www.thefdalawblog.com/2024/07/fda-releases-draft-guidance-on-essential-drug-delivery-outputs/?utm_source=rss&utm_medium=rss&utm_campaign=fda-releases-draft-guidance-on-essential-drug-delivery-outputs For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. EPRs were usually requested in the context of design controls, although 21 C.F.R. § 820.30 does not use this term. In various meetings with the Agency and at conferences, FDA was often asked to clarify this term. Are EPRs the same as “Essential Performance” as defined in IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance? Are EPRs design outputs that are essential for the proper functioning of the device that are required to be identified per 21 C.F.R. § 820.30(d)? Are EPRs a new term to describe a subset of design input requirements and specific to combination products?