The Food and Drug Administration (FDA or the Agency) has answered the most important questions related to importing, registration and listing of medical devices during the pandemic associated with the outbreak of the Coronavirus Disease 2019 (COVID-19).
Importing Medical Devices to the US
The FAQ on importing covers only medical devices intended to be placed on the market under the Emergency Use Authorization (EUA) – a special framework allowing the manufacturers to place their devices on the market before the FDA clearance. The Agency takes special extraordinary measures in order to ensure the availability of vitally important medical devices during the pandemic. In particular, special rules are applicable to the following categories of medical devices:
- Devices covered by a device-specific enforcement policy – such devices should be declared as FDA-regulated. The Agency also states it will not object to certain changes to such devices, providing that upon the changes will take place the device will still comply with the applicable safety and performance requirements.
- Devices covered by the appropriate Emergency Use Authorization.
The FDA describes the way the medical devices actively used in the context of the pandemic could be imported to the US, and also the requirements the importer shall fulfill. The most important points covered by the FDA FAQ include, inter alia, the following ones:
- The FDA does not certify products – the Agency only allows products for marketing and use and adds the appropriate entries to the register. In order to check whether the particular product is FDA-cleared, the interested party may check the databases containing information about the registered medical devices and ones covered by device-specific exemptions. It is also advised to check the information about the devices placed on the market under the appropriate EUA.
- Sterilizers could be imported under the special enforcement policy issued by the FDA. For devices of this type, the FDA is not going to object to certain changes.
- In order to import ventilators covered by the EUA, the importer shall supplement the importation documentation with the signed EUA letter. Depending on the particular ventilator in question, the appropriate Intended Use Code (IUC) should be indicated by the importer.
- Electronic thermometers could be also placed on the market under the special enforcement policy which simplifies regulatory procedures related to such devices due to the important role they are playing in addressing the COVID-19 outbreak. In particular, in some cases, thermometers could be marketed without registration and listing.
- Remote ophthalmic assessment and monitoring devices could be imported under the simplified procedure too, providing that the appropriate Intended Use Code has been indicated.
- Infusion pumps and accessories thereto are also covered by the special enforcement policy allowing the importers and manufacturers of such devices to waive certain regulatory requirements related to the registration and listing.
- COVID-19 tests, which are regulated as in vitro diagnostic medical devices, could be imported either under the Emergency Use Authorization or under the special policy for diagnostic tests for coronavirus intended to be used in the context of the public health emergency. Thus, the appropriate Intended Use Code should be indicated in the importation documentation.
- Each imported medical device regulated by the FDA should be assigned with the appropriate entry number.
Besides the aforementioned, the Agency recommends the importers to supplement the importation documentation with a copy of the signed EUA Letter of Authorization to confirm the regulatory status of the product and applicability of a special framework.
Registration and Listing of Medical Devices in the US
Another FAQ issued by the Agency covers the most important aspects related to the registration and listing of medical devices intended to be marketed and used in the US. The document provides medical device manufacturers and other parties involved (such as suppliers and distributors) with detailed recommendations regarding the requirements they should comply with.
According to the general rule, the entity performing operations with medical devices should be duly registered with the FDA. In the course of such registration, an entity should describe the operation it performs and to provide a list of medical devices. In case if due to the type of the device in question should be subject to mandatory pre-market approval, the interested party shall submit the appropriate application to the FDA. Each entity shall also pay the annual registration fee irrespectively of the applications filed.
Key aspects covered by the FDA FAQ on registration and listing of medical devices are the following:
- to address the COVID-related issues, the Agency has implemented special regulatory frameworks intended to expand and ensure the availability of vitally important medical devices during the pandemic. Such frameworks provide that, if special conditions are met, certain medical devices could be placed on the market under the simplified procedures. The rules are applicable to such devices as infusion pumps, ventilators, COVID tests (that are regulated as in vitro diagnostic medical devices), and also to the personal protective equipment.
- The FDA FAQ contains general information and links to the detailed description of the registration process the entity shall follow. In particular, the entity applying for the registration should use the FDA Unified Registration and Listing System (FURLS).
- There are no waivers related to the annual registration fees payable by the entities involved in operations with medical devices.
- Each medical device should be listed with the appropriate product code. In case of any discrepancies between the product code and description of the device, the listing should be removed and replaced with the correct one. In case of any doubts regarding the correct code to be assigned, the entity should use the Product Classification Database.
- The FDA Establishment Identifier (FEI) is a special number confirming that the particular entity has been properly registered with the FDA. Upon registration, the Agency will publish the aforementioned number in the Establishment Registration & Device Listing database where it could be found by the interested parties. It usually takes up to 7 days for the authorities to make the information about the entity publicly available, so if the entity is going to check it before, it would be necessary to access a special section using login credentials. For the first time, the information will be published without a registration number since it usually takes up to 90 calendar days for the Agency to assign a registration number. The same database could be used by the entities that are going to purchase medical devices and thus are seeking the opportunities to verify the information related to the counterpart and its regulatory status.
Registration and Listing of Certain Medical Devices During the COVID-19 Outbreak
As it was already mentioned before, the Agency introduced special measures simplifying the regulatory procedures to be performed when placing new medical devices on the market in case if such devices are intended to be used in the COVID-related context.
In particular, the following points should be considered:
- An entity importing medical devices for its own purposes should not be subject to mandatory registration and listing.
- Medical devices placed on the market under the EUA framework should be registered and listed with the references to the appropriate EUA letter of authorization.
- The Agency also does not intend to object to certain modifications to the FDA-approved medical devices, providing that the impact caused by such modifications does not affect the risks associated with the use of the devices, or if the benefits are exceeding the appropriate risks.
How Can RegDesk Help?
RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.