Abstract

The term ‘essential performance requirement’ (EPR) was introduced to the pharmaceutical industry in communications from the Food and Drug Administration (FDA) around 2019, but with no accompanying formal guidance, leading to confusion within the industry on how to interpret requirements for drug-device combination products.

‘EPRs’ have mistakenly been equated with requirements such as:

• ‘Primary functions’ (ISO 11608: Needle-based injection systems)^[1]
• ‘Design input requirement’ (21 CFR 820.30, US regulation of design control for medical devices^[2] and ISO 13485:2016,^[3] an internationally agreed upon standard that sets out the requirements for a quality management system specific to the medical devices industry)
• ‘Essential performance’ (IEC 60601-1-11:2015: Medical electrical equipment-General requirements for basic safe and essential performance”)^[4]
• ‘Essential principles’ (as defined in the International Medical Device Regulators Forum (IMDRF))^[5]

The lack of alignment between existing terminology has contributed to further challenges. This article delves into the FDA June 2024 EDDO draft guidance^[6] and addresses confusion with which industry is contending.