As we understand the FDA’s Guidance, the Emergency Use Authorization (“EUA”) is directed primarily to non-medical-device manufacturers that, because of the Covid-19 pandemic, are temporarily shifting from their traditional production to the manufacture of Personal Protective Equipment (“PPE”). These manufacturers cannot comply with the FDA’s labeling and good manufacturing standards, among other FDA requirements. Because of the emergency, the FDA has waived many of its requirements and allowed this PPE to be sold under the EUA.
Augustine Surgical, Inc. is a medical device manufacturer, experienced in meeting all FDA requirements. As such, it has no need of the waivers provided by the EUA.