N95 Respirators and Surgical Masks (Face Masks), Filtering Facepiece Respirators (FFRs), are Personal Protective Equipment (PPE) and medical devices.
Keep that in mind before you import these products from China, India, South Korea, or any other countries.
For the duration of the public health emergency, FDA does not intend to object to the distribution and use of face masks, with or without a face shield (not including respirators), that are intended for a medical purpose (whether used by medical personnel or the general public), without compliance with the following regulatory requirements, where the face mask does not create an undue risk:
■ Prior submission of a premarket notification
■ Registration and listing requirements
■ Quality system regulation
■ Reports of corrections and removals
■ Unique Device Identification requirements
Such devices would not create an undue risk where:
• The product includes labeling that accurately describes the product as a face mask (as opposed to a surgical mask or filtering facepiece respirator – FFR) and includes a list of the body contacting materials
(which does not include any drugs or biologics)
• The product includes labeling that makes recommendations that would reduce sufficiently the risk of use. The labeling recommends against use in any surgical setting or where significant exposure to liquid, bodily or other hazardous fluids, may be expected; use in a clinical setting where the infection risk level through inhalation exposure is high; and use in the presence of a high intensity heat source or flammable gas
• The product labeling does not include uses for antimicrobial or antiviral protection or related uses or uses for infection prevention or reduction or related uses and does not include particulate filtration claims.
Manufacturers, exporters, Initial U.S. Importers must be registered with the FDA as Medical Device Establishment. Current FDA User Annual Fee is $5,546.00 (expected to increase on October 1, 2021), whether a Premarket Notification 510(k) is needed or not.
Make sure your company has a DUNS Number.