Thank you for stepping up! Check out the below site. It gives you ways to contact FDA and does state expedited reviews.
FAQs on Shortages of Surgical Masks and Gowns
| U.S. Food and Drug Administration |
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| FAQs on Shortages of Surgical Masks and Gowns |
| The FDA is aware that as the COVID-19 outbreak continues to expand globally, the supply chain for these devices will continue to be stressed if demand exceeds available supplies. We have received information from healthcare organizations that some distributors may have placed certain types of personal protective equipment (PPE) on allocation, basing the quantity available to the healthcare organization on previous usage, not projected use. |
| View this on U.S. Food and Drug Administration > |
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There are other resources available too, but the email provided at this site would probably get you a response the fastest.
Best Regards,
------------------------------
Andrea Pilon Artman, MS, CQE, RAC
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA
andrea.artman@spectracompliancellc.com------------------------------
Original Message:
Sent: 20-Mar-2020 14:27
From: Anonymous Member
Subject: Regulatory clearance pathways for surgical masks/N95 respirators
This message was posted by a user wishing to remain anonymous
Hello Everyone,
Is there are any expedited/emergency use regulatory clearance pathways for surgical masks/N95 respirators due to the COVID-19 outbreak?
Thanks,