Per the Federal Food, Drug, and Cosmetic Act (FD&C Act), the US Food and Drug Administration allows for the emergency use of some medical products under certain circumstances. An Emergency Use Authorization (EUA) provides FDA with the authority to support emergency preparedness and response, including supporting the development and availability of unapproved or new medical products (drugs, biological products and medical devices) for use in emergency situations.
The Fang Consulting team supports EUA strategy and applications with a solid understanding of FDA requirements for COVID-19 related EUAs; we continue to keep abreast of changing requirements as they evolve throughout this time of emergency due to the current, global coronavirus pandemic. From providing strategic pathways for navigating various EUAs for COVID-19 products to developing commercial use plans for products available under EUAs, Fang Consulting can advise clients how to achieve their specific short term and long term goals to ensure they align with FDA requirements and guidance.
Our Emergency Use Authorization (EUA) Services
Interpretation of FDA requirements and guidance related to new and evolving EUAs including regulatory pathway options
Regulatory pathways for premarket requirements for continued commercialization after the EUA concludes, such as premarket notification
Pre-EUA submission support
For COVID-19 related EUAs, understand requirements and how client products fit into EUA frameworks
- Support EUAs for IVDs, anti-body tests, PPE (masks, gown, etc.) and other medical devices
- Research and recommend new pathways as FDA revises guidance and EUA scope