FDA Regulatory Framework for Importing Medical Masks to the U.S
It's not a secret that COVID-19 pandemic has caused a major boom in demand for use of medical mask in the US.
FDA Listing Inc. has been dealing with several U.S. importers as well as manufacturers outside the U.S. that are trying to meet this demand. Below is the summary of FDA regulatory requirements for importing medical mask to the U.S.
What are the FDA requirements?... It depends!
In abroad sense, there are two types of masks and FDA requirements for each largely depends on what category the mask belongs to.
One- Masks or respirator that they claim to prevent infections or else are equipped with antiviral or antimicrobial specifications. Filtering respirators, surgical mask for occupational use fall into this category. These masks considered class II medical devices and hence require FDA clearance (510k) prior to entering the U.S. market. Some examples FDA classes for such masks are NZJ , ORW , FXX , OUK .
FDA clearance, premarket notification or 510k refers to the approval process that is required prior to entry of most class II medical device into the U.S. market. Among other things, this process involves providing sufficient evidence to the FDA that can substantiate the safety and efficacy of a medical device -by proving its equivalence to an already approved similar marketed product. Aside from meeting 510k requirements, there are device labeling claims, device establishment registration , device listing requirements to be considered.
Note, due to the current public health emergency, FDA has published an enforcement policy that authorizes the manufacturers to request an Emergency Use Authorization (EUA) to sell certain types of surgical masks without pre-approval by sending an email to CDRH-COVID19-SurgicalMasks@fda.hhs.gov -and complying with the further specifications outlined in the policy.
Two- By the same token, the masks that do not claim to prevent infections and aren't equipped with antiviral or antimicrobial specifications belong to the second category. Masks in this group do not require FDA clearance prior to entering commercial distribution in the U.S.
QKR is a good example for this category; it could be used by manufacturers for listing mask categories that are exempt from FDA clearance. MSH is another FDA class of mask that is exempt form premarket approval if they do not make claims to possess antiviral or antimicrobial properties. In case MSH is used in listing N95 respirators, then a NIOSH approval is required- even though an FDA clearance is not necessary.
Note, FDA currently has two separate lists for non-NIOSH-approved authorized respirators under Emergency Use Authorization (EUA); once is for approved Chinese manufactures and one for all others .
Other Protective Device Categories
Generally, many of the protective devices like face-shields, surgical gowns, and medical gloves and apparels that are designed to prevent spread of contamination in healthcare setting require FDA clearance-510k. However, as an effort to bring in more protective devices into the U.S. the FDA has published an enforcement policy that will allow gowns, gloves and protective apparel to be imported into the U.S. without 510k requirement and facility registration and listing requirements as well as Quality system regulations QSR.
Last rule of thumb; it all comes down to your labeling!
Remember, the recent Emergency Use Authorization (EUA) does not mean FDA is having a complete hands-off approach. FDA will still be still scrutinizing the masks and other protective apparels' labeling for any medical claims, indications for use, .
warnings, etc., before allowing the products to be marketed in the U.S.
FDA Listing Inc. is helping US-based importers as well as manufactures to identify the correct FDA class codes for their products and assist with device labeling claims reviews and device establishment registration and listing . You can call us at 929-378-7870 for immediate help. |
