Couple of months back we thoroughly discussed about FDA’s expedited Regulatory pathways during medical emergencies. In that specific explanation as we listed the FDA’s tools and programs for expedited approvals with respect to review and approval of therapies, including biologics, this time we would like to bring the same perspective in relation to medical devices. Here we go with the US FDA’s perspective on registering, listing and importing medical devices that have been issued Emergency Use Authorization (EUA).
With an aim to increase the availability of medical devices during COVID-19, the US FDA has described the following requirements and procedures for registering and listing the devices and manufacturing facilities. They include:
Registration and Listing
- The Agency has issued device-specific guidance documents for certain ventilators and Personal Protective Equipment (PPE) devices, describing the Agency’s policies concerning the enforcement of registration and listing requirements for facilities that manufacture, prepare, propagate, assemble, or process these devices during the COVID-19 pandemic.
- The US FDA has also issued Emergency Use Authorizations (EUAs) for critical devices, such as, certain infusion pumps, remote monitoring devices, PPE devices, such as N95 respirators and in vitro diagnostics.
- Prior to registering the facility and listing the devices, the facility is required to pay the annual registration user fee. The fee can be paid using the Device Facility User Fee (DFUF) website. After paying the fee and obtaining the Payment Identification Number (PIN) and Payment Confirmation Number (PCN), the facility will need to complete the registration and listing process using the FURLS Device Registration and Listing Module (DRLM). As stated by the Agency, there are no waivers for the annual registration user fee for importers, small business or any other establishments.
- If a device is listed with a product code that differs from the device description, the Agency recommends the user to determine the correct product code for the device in the product classification database.
Confirming Registration and Listing
- A facility is verified as registered, only after receiving an assigned owner/operator number, registration number, or FDA Establishment Identifier (FEI) number. This information is available on the Establishment Registration & Device Listing database. If a facility does not appear in the public registration and listing database, the facility’s registration may be inactive or registered recently. The public registration and listing database is updated weekly.
- The US FDA may take up to 90 calendar days to assign a registration number to a facility. The Agency will send a confirmation email to the official correspondent after assigning a registration number. In the meantime, a facility can use its owner/operator number and device listing number (if applicable) to import its medical devices into the United States.
- To verify the registration status of a facility and the listing status for that facility’s medical devices, purchasers may search the facility’s establishment name in the Establishment Registration & Device Listing database, search criterion.
- The US FDA does not issue any type of device registration certificate to medical device facilities. As stated by the Agency, when a facility registers 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 US FDA does not issue a license to import medical devices into the United States and requires importers to meet the definition of an initial importer found in 21 CFR Part 807.3(g), to register with the FDA.
Registration and Listing Certain Medical Devices for Use During Emergency
- The US FDA requires an individual, organization or other entity importing and selling the masks or PPE to register and list them, as they are likely considered as an initial importer. Additionally, an entity may be required to register, and list as set forth in the device’s Emergency Use Authorization (EUA).
- When imported, the devices should be declared as FDA-regulated with modified market-entry requirements, as allowed by the EUA authorizing your device for emergency use. If required by the device’s EUA letter of authorization, the device must be registered and listed.
As the US FDA continues to work towards protecting the public health by reviewing the registration and shipment procedures of medical devices during the COVID-19, manufacturers must adopt and abide to the Agency’s regulations. For end-to-end compliance and knowledge on Emergency Use Authorizations, consult a Regulatory expert. You can even access our archived webinar session on EUA and Post-EUA scenarios. Stay informed. Stay compliant.