March 6, 2020
COVID-19 has made its way to the United States and has led to a nationwide shortage of face masks. Registrar Corp has received many requests from global manufacturers for assistance with U.S. Food and Drug Administration (FDA) regulations for exporting masks and other infection control devices to the USA in response.
Despite Surgeon General requests for Americans to refrain from making unnecessary mask purchases, retailers find themselves in need of more supply. “Stores across the country have run out of masks,” CNN reported on Monday. “As for online shipments, many orders have been pushed back.” According to our callers, US buyers seem to be seeking new suppliers to supplement existing orders and meet the increased demand.
FDA Requirements for Masks
The first step to exporting masks to the United States is to identify your product code, as this is the determining factor for whether you need clearance from FDA as well as NIOSH-Approval.
Product Codes that Require FDA Clearance
Masks or respirators that claim to prevent infection or have antiviral or antimicrobial properties are considered class II devices and require FDA clearance. Examples of product codes that fit these categories are FXX, OUK, or ORW. Because the product code ORW is used for N95 Respirators, products listed under this code must be certified by NIOSH to filter at least 95% of airborne particles.
Due to the demand during the COVID-19 pandemic, FDA has published an enforcement policy that allows manufacturers to request Emergency Use Authorization (EUA) to market surgical masks and respirators without premarket notification by emailing [email protected]
Product Codes that Do Not Require FDA Clearance
Masks that do not claim to prevent infection or have antiviral or antimicrobial properties do not need FDA clearance. Manufacturers that make 510(k)-exempt masks may use product code QKR. Surgical respirators under product code MSH are also exempt from FDA clearance so long as they do not make such claims and they demonstrate the ability to resist penetration by fluids (such as blood and body fluids) at a velocity consistent with the intended use of the device. Note that MSH is also used for N95 respirators, so although masks listed under this code do not need FDA clearance, they still must be NIOSH-approved.
Manufacturers of masks that do not require FDA clearance need only to register their establishment with FDA and list their products.
How to Obtain FDA Clearance when Required
Manufacturers can obtain a clearance letter from FDA by submitting premarket notification, known as a 510(k), to the Agency. 510(k)s are intended to prove to FDA that a product is substantially equivalent (same intended use and equally safe and effective) to one already on the market.
Among other things, a premarket notification submission must include your device class and proposed labeling. 21 CFR 807 outlines the full requirements of a 510(k) submission. Once you receive FDA clearance of your 510(k), you must register your establishment with FDA and list your products before shipping.
Note that FDA has established Emergency Use Authorizations due to Coronavirus and is exercising enforcement discretion for certain device regulations. In response to the pandemic, the Agency has stated that it may consider expedited review of manufacturing site changes or premarket submissions to help alleviate supply pressures.
Other Infection Control Devices
Medical gloves and ventilators intended to prevent contamination between doctor and patient do require a 510(k), but not all of the infection control devices in high demand require such rigorous review. Protective eyewear and surgical suits (not to be confused with surgical gowns, which are class II) are considered class I devices and do not require a 510(k). Manufacturers of 510(k)-exempt devices still need to register with FDA and list their products.
FDA consulting firm, Registrar Corp, can help manufacturers identify the product codes and FDA requirements specific to their devices. You can contact Registrar Corp by email at [email protected] or by calling any of our 20 global offices.