On March 28, 2020, the FDA published guidelines authorizing the use of imported Non-NIOSH-Approved N95 respirator masks (see Page 4, Table 1 from this FDA document (2)) which excluded any N95 masks manufactured in China. This is in contradiction to the CDC guidelines which allow the use of Chinese N95 masks in crisis situations (see the first table from this CDC webpage (3)).

These confusing contradictory guidelines from the FDA and CDC will only serve to turn away donors of N95 masks to hospitals and also cause hospital administrators to reject N95 mask donations for the fear of liability.

China is the world's largest manufacturer of N95 masks and there is no way the other countries/entities on the FDA's approved list (Australia, Brazil, Europe, Japan, South Korea & Mexico) could fulfill the US's requirement for 3.5 billion N95 masks, even if they agreed to export whatever surplus masks they had to the US. Whatever plans in the works to manufacture or source N95 masks within the US will not alleviate the shortage in time for the hospitals that are in the direct path of, and in the frontlines of the pandemic.

Doctors and nurses have a much higher than normal risk of getting severely ill with Covid-19 despite their younger age (see this CNN article (4)) and they need the protection of N95 masks, each of which has a lifespan measured in hours. If our doctors and nurses start succumbing to Covid-19 due to the lack of protective equipment, an Italy-style collapse of our healthcare system is inevitable. 

Demand that the FDA urgently issue a clarification stating that it is acceptable to use Chinese N95 masks which meet Chinese GB 2626-2006 standards in concordance with CDC guidelines for crisis situations.

References:

1. FDA, "Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices" Web Page, https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ppe
2. FDA, "Guidelines for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators", March 28, 2020, https://www.fda.gov/media/136403/download
3. CDC, "Strategies for Optimizing the Supply of N95 Respirators: Crisis/Alternate Strategies", March 17, 2020, https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/crisis-alternate-strategies.html
4. CNN Health, "Health care workers getting sicker from coronavirus than other patients, expert says", March 19, 2020, https://edition.cnn.com/2020/03/16/health/doctors-coronavirus-health-care-hit-harder/index.html