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Guest user Created:   Oct 26, 2021 Last commented:   Oct 27, 2021

FDA

We are not a manufacturer of medical devices; we have designed and built a ventilator that we intend to submit to FDA for EUA approval. It is a novel design which has several advantages over current ventilators and is patent pending through PCT; two questions for you: 1.  Does the EU has also an emergency use authorization as FDA does for medical devices, specifically ventilators? 2. Are you familiarized with the process for EUA Authorization of the FDA?
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Oct 27, 2021
1. Does the EU has also an emergency use authorization as FDA does for medical devices, specifically ventilators?

Yes, the EU also has a strategy rescue stockpile of medical equipment for COVID-19. All details you can find on the following link: https://ec.europa.eu/commission/presscorner/detail/en/ip_20_476  

2. Are you familiarized with the process for EUA Authorization of the FDA?

Yes, we are familiar with the information that can be found on the Internet. Feel free to ask what interests you.

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Oct 26, 2021

Oct 27, 2021

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