Personal Protective Equipment EUAs

Personal Protective Equipment (PPE) refers to protective clothing, helmets, gloves, face shields, goggles, respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness.

To help address concerns about availability during the COVID-19 pandemic, the FDA has issued Emergency Use Authorizations (EUAs) for certain PPE products including face shields, other barriers, and respiratory protective devices such as respirators. Additionally, the FDA has issued recommendations and policies about PPE which can be found here: Recent Final Medical Device Guidance Documents.

Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including an Interactive Review Template For Non-IVD Products. Additionally, the FDA has posted a Surgical Masks EUA Template for Addition to Appendix A of the Surgical Mask Umbrella EUA.