FROM A GLOBAL PERSPECTIVE
By Vanessa Shaw-Dore, Scott Gonzalez, Meisha Sampson, and Melissa Torres
March 29, 2021
A significant number of medical devices are imported into the United States from China every year. This number has grown substantially over the last 12 months as the COVID-19 pandemic has boosted demand for Chinese-made devices, including certain personal protective equipment (PPE — respirators, gloves, gowns, etc.); COVID-19 tests and sample collection devices; and analytical instruments.
Unfortunately, some companies have used so-called registration certificates to create the misimpression that the FDA has reviewed, approved, cleared, or authorized their device, which leads to public health concerns. Specifically, misleading impressions caused by use of the registration certificates are especially concerning because purchasers rely on information provided by sellers to determine whether to purchase a device, and are likely to believe that accompanying certificates imply that the device has been reviewed and approved by the FDA.
Foreign companies seeking to export medical devices to the United States generally must register their facilities and list their devices with the FDA. This applies to foreign manufacturers, repackagers, and other specified entities located not only in China but anywhere else in the world. Once registered, the companies receive a unique FDA registration number as well as unique listing numbers for their medical devices. When the devices are exported to the U.S., this registration and listing information is typically submitted to U.S. Customs and Border Protection by hired customs brokers and then reviewed by the FDA’s import data system and port personnel. The registration and listing numbers submitted must be valid, match up with each other, and be correct for the particular product being shipped, for an entry to proceed into the U.S.
It turns out that some companies in China and the U.S. view a device registration as much more than it is. The Office of Global Policy and Strategy’s China Office (CNO), working with the FDA’s Center for Devices and Radiological Health (CDRH), has identified companies that imply registration is the same as FDA approval of the company and its devices, and/or who may not know what it means to be registered. Stakeholders, including the public, may unknowingly rely on a misleading document that is sometimes called an “FDA registration certificate” as “evidence” that the device or establishment has some kind of FDA stamp of approval. In fact, that’s not the case — the FDA does not issue registration certificates to medical device establishments. And yet, as the FDA has learned, these misleading certificates, which are occasionally included in the device’s import entry documentation package, are also regularly shared with stakeholders throughout the supply chain — from the device manufacturer down through the importer.
Sometimes companies hire a third party to assist them with FDA registration. It is important to recognize that when companies do so they are simply making a business decision. The FDA does not require or prohibit a device manufacturer, repackager, or exporter to hire a third party to complete the online registration process, nor are such third parties affiliated with the FDA. Furthermore, the agency does not contract with any businesses to register facilities, nor does the FDA use any outside contractors to notify industry about the need to register.
The practice of producing and issuing misleading registration certificates not only may cause confusion, which alone can pose a public health concern, but the concern is increased when these certificates look like an official government document and display the FDA logo. Companies that misleadingly display certificates alongside information and photos of a device for sale in the U.S. and thus imply that the FDA has reviewed or approved the device, misbrand the device in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
CNO has helped to identify this problem. Every month the office contacts newly-registered facilities in China to confirm the information they provided to CDRH on their registration and listing forms. During that process CNO helps to ensure that:
- The facility intends to ship product(s) to the U.S.
- The registered facility manufactures “devices” as defined by the Act.
- The facility’s physical location and contact information are correct.
Registration, What It Really Means
Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States are generally required to register annually with the FDA. It is important to understand the limitation of what it means when a company registers its facility and lists its devices:
- The resulting entry in the FDA’s registration and listing database does NOT denote approval, clearance, or authorization of that facility or its medical devices.
- The FDA does NOT issue registration certificates to medical device facilities.
- The FDA does NOT “certify” registration information for businesses that have registered and listed.
Not surprisingly, the surge of imported PPE in 2020 during the COVID-19 pandemic and the associated increase in companies registering with the FDA has led to a rise in the use of misleading certificates. This, in turn, has pointed the way for CDRH to take action. In March 2021, CDRH sent letters asking companies that produce and issue FDA registration certificates — including some bearing the FDA logo — to cease doing so. Sixteen of the 25 companies that received the “general communication letters” from CDRH are located in China, and the rest are located in the United States.
Why the FDA issued letters to producers and issuers of registration certificates
Given the stepped-up global demand for medical devices used to respond to COVID-19, issuing these letters now, during the COVID-19 pandemic, takes on heightened importance from a public health standpoint. Whether issued by third parties as a form of receipt, or by importers as part of the supply chain documentation, or posted on a manufacturer’s or distributor’s website to imply FDA approval or review, certificates such as these may mislead recipients and purchasers.
Moreover, entry documentation lacking registration and listing, as generally required, may result in further review or detention at U.S. ports. Such a delay can pose a public health issue when medical devices are in high demand during the COVID-19 pandemic.
The Office of Global Policy and Strategy’s China Office is continuing its efforts to educate Chinese companies that “certification” of FDA registration and having registration certificates fulfills no other purpose but for display, implying — albeit erroneously — FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the establishment or device. We are proud to be playing an important role in monitoring the registration and listing of Chinese companies — including those making COVID-19-related devices. After all, at stake is the health of the American public.
Vanessa Shaw-Dore, M.P.H., is the Director of the China Office, within the Office of Global Policy and Strategy.
Scott Gonzalez is an International Relations Specialist within the Office of Global Policy and Strategy’s China Office.
Meisha Sampson, M.S., is a Supervisory Consumer Safety Officer within the Office of Global Policy and Strategy’s China Office.
Melissa Torres, M.E., M.S., is the Associate Director of International Affairs within the Center for Devices and Radiological Health.