The Nemedio Blog:  Demystifying Compliance

your guide to product development and compliance for medical technology
FAQ, Regulatory

EUA is over - what does that mean?

June 10, 2022

Emergency Use Authorization came into our collective vocabularies with the pandemic. Not a day passed when a new company didn’t make promises of 1 hour, 10 minutes, 1 minute fast testing, or the great news of vaccines being released under this mystical term. The mass media and public became skeptical, perhaps due to the terms used. Does this mean a short cut? Did they not bother testing and just approved it and hoped for the best? Not exactly.

The FDA review process for medical and pharmaceutical devices follow the same basic principles. You generate a product prototype, then create a quality system capable of tracking the tests you aim to use to prove the safety and effectiveness of the said product. Once these are complete, you submit them to the FDA and hope for an approval. In EUA, the extent of the quality system you had to have was significantly reduced to allow fast submissions and remove red tape. This did not mean eliminating tests for safety and effectiveness however, just less paperwork. Additionally, the paperwork and documentation necessary for any future issues doesn’t just magically go away forever. This is not a golden ticket for all companies to wait for. Once the EUA expires, and the FDA has already indicated that it will soon, all the backlogged paperwork will have to be completed by companies currently marketing the devices under this clause. They will essentially be transferred to their appropriate product categories with the rules that govern their regulations. The deadline for proposed plans to adhere to appropriate classifications was March 23rd, 2022. Companies which have not proposed their plans will be forced to stop marketing their products. Before they can restart marketing, after their presumed FDA clearance, they will need fully compliant quality systems. 

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