Fast- Track under COVID- 19 for Health Canada & FDA

Health Canada

For manufacturers that want to fast-track under Covid-19, the medical device must be manufactured, sold or represented for use in relation to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). More information here.

FDA

For manufacturers that want to fast-track, either FDA must issue an Emergency Use Authorization (EUA) for or the manufacturer may submit a Pre-EUA to request a new EUA be authorized. Currently there are 3 EUAs associated with Covid-19: Ventilators (March 24), Rapid Test Assays (includes wavier for labs to have CLIA), and NIOSH N95 masks. More information here.  

Looking for assistance with fast-tracking for COVID-19?

Arazy Group has successful experience, already!


* Note: If you use your general ISP e-mail address, such as gmail, yahoo etc. your LinkedIn profile address is required to process your request.