Emergency Use Authorisation Services
EUA Preparedness and Submission
Navigating the Emergency Use Authorisation (EUA) process can be challenging. Our team can help you determine if obtaining an EUA is an option for your medical device product. We can guide you in planning for your EUA and developing submission documentation, ensuring an efficient and timely submission process.
Post EUA Documentation
Issuance of an EUA does not indicate FDA clearance or approval. The product is authorised only during the public health emergency. Once the EUA is no longer effective, you will need to obtain the appropriate FDA clearance or approval to continue commercialisation of your product. Our team can help you determine and comply with the applicable regulatory requirements under EUA and following the COVID-19 pandemic, including premarket submissions such as 510(k) and the Quality System Regulation (21 CFR 820).