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QUOTED. 27 March 2020. US FDA.

Executive Summary

Manufacturers of some medical face masks won't need US Food and Drug Administration clearance to sell their wares under an immediately in effect guidance document issued on 26 March. See what the FDA said about it here.

“FDA welcomes the opportunity to work with manufacturers not previously engaged in medical device manufacturing with the interest and capability to manufacture face masks and respirators. This may include US manufacturers in other manufacturing sectors.” – US FDA

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