Guidance on manufacturing non-surgical face masks

#1
Due to Covid-19, my company (in USA) is considering starting manufacturing face masks. I have been searching and have not been able to find answers to the following questions. Any guidance would be welcome.

I understand surgical masks are considered class II by FDA. We currently are FDA registered and have cut and sew capabilities for class I orthopedic devices and do not want to move to class II.

1. Are non-surgical masks considered medical devices?
2. If so, are they class I?
3. If class I, are there any clean room requirements?
4. If not a medical device, are there any other requirements that anyone is aware of? I can only think of any claims that we could not make.
5. If we were to act as a contract manufacturer for the class II surgical mask, would they need to be made in a cleanroom?
 
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Golfman25

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#2
Due to Covid-19, my company (in USA) is considering starting manufacturing face masks. I have been searching and have not been able to find answers to the following questions. Any guidance would be welcome.

I understand surgical masks are considered class II by FDA. We currently are FDA registered and have cut and sew capabilities for class I orthopedic devices and do not want to move to class II.

1. Are non-surgical masks considered medical devices?
2. If so, are they class I?
3. If class I, are there any clean room requirements?
4. If not a medical device, are there any other requirements that anyone is aware of? I can only think of any claims that we could not make.
5. If we were to act as a contract manufacturer for the class II surgical mask, would they need to be made in a cleanroom?
Call the White House, FDA, your Senator so they can direct you to the proper person to grease the skids for you. Good luck.
 

MDRexpert

Involved In Discussions
#4
Can someone explain how NIOSH plays role in approval of surgical masks?
Also, if someone can share a link or information on the CDC requirements for surgical as well as non surgical masks. The CDC governs NIOSH but what authority does CDC have ? and how do they interact with the FDA?

What are the audit requirements for CDC? and how do they enforce their authority in terms of non-compliance?
 
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