At times of chemical, biological, radiological, and nuclear (CBRN) emergencies, the EUA authority allows FDA to facilitate the availability and unapproved usage of medical countermeasures (MCMs) as specified in the Federal Food, Drug and Cosmetic act (FD&C Act), section 564. EUA has been issued by the FDA due to COVID19 pandemic.
The issued EUA may entitle manufacturing facilities of medical and non-medical devices to obtain temporary approval to produce and/or import the needed supplies of PPE, ventilators, masks, etc. This depends on risk-benefit analysis, emergent need, the shortage of approved alternatives and the proved efficacy of the proposed product. Despite the FDA waivers of some of the requirements of the regular clearance process, submission for EUA requires specific evidence of safety, efficacy, need, description of the product details and approval status.
Globiox’s team of experts can help you obtain FDA EUA for your products and sustain the clearance after the EUA expires. Contact us for an exploratory meeting to discuss your unique situation, your goals, and time line.
Our services offering with regard to EUA include but are not limited to:
-Pre-EUA submission & EUA submission
-Quality Management System assessment, creation, and implementation.
-Product Labeling Compliance
-Compliance testing, documentation, etc....
-General ad hoc guidance