SUMMARY OF FDA GUIDANCE FOR MASKS AND FACE SHIELDS

TRADELABOR has more than 20 years of experience in the control and treatment of air, working with an experienced and qualified technical staff and with the most advanced technology in this area, which together guarantee the quality of the services provided.

 

 

Provided that a surgical mask does not create an undue risk, the FDA will not object if other
FDA regulations for medical devices are not satisfied, including:

 site registration and product listing under 21 CFR 807;

 prior submission of a premarket notification under Section 510(k) of the FD&C Act and
21 CFR 807.81;

 good manufacturing practices under 21 CFR 820 (design, manufacture, packaging,
labeling, storage, and distribution);

 reporting, correction, and product removal requirements under 21 CFR 806; and

 device identification requirements under 21 CFR Part 830 and 21 CFR 801.20.

 

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