Update 6/10/2020
On June 6, 2020, the FDA made several changes to EUAs for certain N95 respirators and Non-NIOSH-Approved Disposable Filtering Facepiece Respirators. FDA issued EUAs for products used to decontaminate certain N95 respirators for multiple-user reuse by HCP. Based on testing conducted by the CDC NIOSH on respirators made in China, FDA has now determined that, generally, authorized respirators made in China would not be authorized after decontamination.
Update 05/07/2020
FDA issued a revised Emergency Use Authorization (EUA) for “disposable filtering facepiece respirators (FFR) manufactured in China that do not meet NIOSH standards.” This comes as a result of questions about the ability of the respirators to meet a minimum particulate filtration efficiency of 95% when testing by NIOSH.
Note: This blog was updated 04/13/2020 to reflect new FDA guidance and activity.
In recent blogs, we’ve provided an overview of importing face masks and also described the Emergency Use Authorization (EUA) for disposable facepiece respirators. Today, we have a stern warning for Customs brokers, importers and U.S. distributors. Soon, we will be providing a checklist for Brokers to begin to ask questions of their importer clients.
Over recent days and weeks we have seen a significant increase in counterfeit or fraudulent respirators/face masks and certificates. Understandably, people want to get as many medical face masks to market as possible, but none of us want to see non-surgical masks accidentally used in surgical settings – or worse, seeing little more than non-medical masks in any hospital setting. All masks must be appropriately listed, labeled and cleared (as needed) for their approved intended use.
[NOTE from Ben England: Why does it matter, you may ask, if non-surgical masks (or gloves or gowns) make it into surgery? That question alone should answer itself – doctors and nurses are hanging over an open human body. Non-sterile gloves inside your body? Doctors and nurses wearing non-surgical masks being splattered by HIV-infected blood? ‘Nuff said – Please, people, protect these heroes and do not sell, purchase, import or clear devices that are NOT surgical but are listed or labeled as surgical.]
Which Masks Meet Which Standards?
CE marks:
If you have a certificate that claims something is CE marked and it’s not issued by a notified body on this list, then it’s not worth the paper it is printed on except MAYBE as evidence to substantiate a claim under the Federal Trade Commission “not misleading” standard – MAYBE. It is not evidence of European marketing authorization and it cannot be used to support the Food and Drug Administration’s (FDA) EUA either.
There are no laboratories in China capable of issuing a CE marketing authorization certificate. All of the Notified Bodies are in Europe. But note, there are many voluntary certification labs in Europe that are not Notified Bodies. A certificate that is not issued by a Notified Body is not evidence of a CE mark or authorization to market in Europe. There are no “CE equivalents” recognized by FDA, only those issued by a Notified Body. Further, if the box of a mask or glove or gown or any other product bears a CE mark (or the “Chinese Export” version of “CE”) but the article does not have EU market authorization, the article is misbranded – at least – and arguably could be considered a counterfeit.
Counterfeit CE:
Further, if the box of a mask or glove or gown or any other product bears a CE mark (or the “Chinese Export” version of “CE”) but the article does not have EU market authorization, the article is misbranded – at least – and could be considered a counterfeit. One blogger joked several years ago that CE means “Caveat Emptor”. Funny, but sad and true today.
“N95” and Similar Designations:
When any mask comes into the United States with N95 marking on it or its box, the manufacturer must be listed on CDC’s site or it is a counterfeit product and is subject to seizure. No product can bear any NIOSH designations unless it has been approved by the National Institute of Occupational Safety and Health (NIOSH). It does not matter what certificate you have been given. Look it up on the site before you buy it.
KN95: Updated as of 4/13/2020
In an April 3, 2020 memo, FDA expanded the EUA to include certain non-NIOSH-approved masks manufactured in China. These are commonly known as “KN95” masks and everyone seems to have them, but many people do not know what to do with them.
FIRST (KN95): FDA did NOT blanket authorize KN95s for use in place of N95s or FDA 510(k) cleared masks for surgical use. So, do not purchase or sell a KN95 as a surgical anything. Please think of the heroes in the OR before you think about your balance sheet or your income statement (let that sink in – lives before money).
SECOND (KN95): While FDA is not stopping the importation of KN95s generally, if importers are looking to sell these masks as a surgical mask, then they must be from manufacturers who have met FDA’s criteria to be eligible under the EUA. Those manufacturers are identified on the EUA’s Appendix A.
THIRD (KN95):For importers of masks not made at one of the authorized manufacturers, they can be imported as a KN95 medical – NON-SURGICAL mask; however, they cannot claim to be a surgical mask. In fact, affiliated Attorney Ben England advises importers to add a non-surgical disclaimer to the label and packaging to help reduce the likelihood that these masks will be used inappropriately in a healthcare setting. As we have said repeatedly, the claims made on the labeling are critical to how FDA and end-users will view (and USE) these products.
FDA Device Listing and Labeling:
FXX: Any third-party FDA registration/medical device listing certificate that lists a mask under the Product Code FXX, but the manufacturer does not own a 510(k) for the device as a surgical mask (and thus the mask is not in FDA’s 510(k) database), then it is a fraudulent listing, the device is adulterated and misbranded and is subject to seizure. Look it up on the site before you buy it.
MSH: If you have a third party certificate of FDA registration/medical device listing claiming the device is classified under Product Code MSH and the manufacturer is not listed on CDC’s site as a NIOSH approved respirator/mask it is also a fraudulent listing and subject to seizure. Look it up on the site before you buy it.
QKR: If you have a purported FDA medical device listing of a mask or a respirator under Product Code QKR and the manufacturer/device is not listed on FDA’s EUA approved recognized mask producers site, then it is a fraudulent listing and subject to seizure.
Updated 04/13/2020
FDA now has two lists under the EUA of non-NIOSH-approved authorized respirators: one for Chinese manufacturers and one for all others. No one should be using QKR unless they already have gone through the appropriate EUA – that product code is ONLY for EUA approved devices.
If someone is offering to sell you a mask that doesn’t look like a respirator it is probably not going to be a NIOSH approved device and it’s probably not going to be NIOSH approvable. If the box says N95 and it is not NIOSH approved, then the product is counterfeit.
Updated 04/13/2020
KHA: Any KN95 mask or rectangular disposable mask listed as KHA is from a manufacturer who was probably making teddy bears last month and now wants to sell you medical equipment to put on the faces of the nurses and doctors in your community hospitals. You feel good about that? KHA is a scavenging mask, not a medical mask or procedure mask or respirator.
THIS is a scavenging mask:
FDA: CEO and Founder Ben England commented, “I love this one.” If you get a device of ANY KIND and its label says “FDA” on it, that device is misbranded. You can never put “FDA” on your device label – not ever.
It is Critical to Get This Right
Fraudulent FDA certificates and counterfeit products are likely to be stopped at the border and if not, they could be life-threatening if used erroneously by healthcare workers. If your supplier doesn’t know how to do this right, you need to tell them how to do it or send them to someone who can. If importers and brokers tell foreign suppliers that all they need is an “FDA number” then they are perpetrating the fraud.
Chinese masks are being recalled in Europe for reasons such as “the masks didn’t fit properly” or “had defective filter membranes to stop the transmission of the virus.” You run the risk that you are going to get these kinds of masks if you accept these fraudulent certificates.
And on top of it all, China is squeezing the carriers and the carriers are beginning to increase their cost substantially for freight coming out of China. If it used to cost you $400,000 to move cargo, that cost could be well over $1 million now. It doesn’t matter what your terms are with the manufacturer, what matters is what you are going to pay on the freight. We have evidence that this is happening. And if you are also getting fraudulent or counterfeit product you have wasted a lot of money and put a lot of first responders and health care workers at serious risk.
Updated 04/13/2020
Customs and Advanced Notice: A few weeks ago, Customs instructed the Customs broker community to provide ADVANCE NOTICE when importing PPE. If you do not give Customs advance notice, they will probably stop and examine your cargo. Because they are busy they will probably take the air waybill (AWB) from the carrier and get back to you in a week or so when they have time to look at the cargo. If you try to move your goods – you won’t be able to because the carrier can’t release the goods to you.
If you are in doubt as to whether the face masks or other PPE you want to import are properly classified and if they need FDA approval or facility registration, ask our team of regulatory consultants and affiliated attorneys. Contact us today.
This blog is provided for informational and educational purposes only and does not constitute legal advice, and is not intended to form an attorney-client relationship. Please contact your regular FDAImports representative for additional information.
