On March 28, 2020, the US FDA issued the latest EUA on masks, clearly announcing that it has officially authorized a batch of foreign standard masks that have not been authorized by NIOSH and can be directly used for epidemic prevention. COVID-19, replacing personal protection for people exposed due to lack of FFR. This reminds people that as early as March 17, the U.S. Centers for Disease Control and Prevention (CDC) released “Optimizing N95 Mask Supply Strategy: Crisis/Alternative Strategies”, pointing out that during the COVID-19 epidemic, when the supply of N95 masks is insufficient, press The standard production masks in the table are suitable substitutes for N95 masks.
CDC original link address: https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/crisis-alternate-strategies.html
However, what is surprising is that the latest EUA released by the FDA this time does not include the Chinese KN95 in the list of foreign standard masks that are not authorized by NIOSH and are allowed to be used. Face mask. How is this going? FDA original text link: https://www.fda.gov/media/136403/download
To understand this, let us first understand the US CDC and What kind of agency is the FDA and what are its main responsibilities?
CDC’s full name is Centers for Disease Control and Prevention, which is the U.S. Centers for Disease Control and Prevention. Its purpose is to coordinate national health control programs when faced with specific diseases. The role of the CDC is to detect and respond to emerging health threats, solve the largest health problems causing death and disability among Americans, and put science and advanced technology into practice. Actions to prevent disease and promote healthy and safe behaviors, communities and environments.
FDA sometimes stands for the United States Food and Drug Administration. FDA is authorized by the U.S. Congress, the federal government. It is the highest law enforcement agency specializing in food and drug administration. It is also a professional body composed of doctors, lawyers, microbiologists, chemists, statisticians and other professionals dedicated to protecting, promoting and improving The government health control monitoring agency for national health. Many other countries seek and receive assistance from the FDA to promote and monitor the safety of their own products.
Simply put, CDC is equivalent to my country’s Center for Disease Control and Prevention, and FDA is equivalent to my country’s Food and Drug Administration.
After carefully reading the CDC report again, it can be seen that on March 17, the U.S. Centers for Disease Control and Prevention (CDC) released the “Optimizing N95 Mask Supply Strategy : Crisis/Alternative Strategies”, it is only recommended to use the masks in the table. Note that this is only a suggestion.
The FDA is the agency that makes the decision, so there will be situations where the final list released by the FDA does not match the list released by the CDC.
Remind the majority of enterprises:
1. Judging from the documents released by the FDA this time, currently Chinese mask products entering the United States still need to undergo FDA or NIOSH certification.
2. There are many fake certificates at present. Companies need to be cautious when applying for product certification to avoid being deceived.
