FDA Eases Import Requirements for Devices and PPE to Fight Coronavirus

Regulatory NewsRegulatory News | 25 March 2020 |  By 

To increase the availability of personal protective equipment (PPE) and other medical devices amid the coronavirus disease (COVID-19) pandemic, the US Food and Drug Administration (FDA) on Tuesday eased import requirements for certain products.
Typically, companies importing FDA-regulated products are required to submit entry information to the agency for the products.
However, to ease burdens on importers and speed up the entry process for PPE and certain devices intended for emergency use or covered by an enforcement discretion policy, FDA is reducing the amount of information that needs to be submitted.
For non-FDA regulated PPE meant for general or industrial use, FDA says that entry information should not be sent to the agency and instead importers should transmit entry information to Customs and Border Protection (CBP). Importers are also instructed to use the appropriate harmonized tariff schedule (HTS) code for the product, either without an FD Flag, or with an FD1 flag and a “disclaim” for FDA.
For products covered by an emergency use authorization (EUA), including diagnostics, masks and respirators, FDA says it is reducing the amount of information that needs to be submitted for its review. Currently, there are 15 diagnostics with EUAs and National Institute for Occupational Safety and Health (NIOSH) approved disposable respirators have been cleared for emergency use in response to a request from the Centers for Disease Control and Prevention (CDC).
For those products, FDA says importers should transmit an Intended Use Code of 940.000: Compassionate Use/Emergency Use and the appropriate product code for the device.
On Tuesday, FDA also issued an EUA for certain non-NIOSH approved respirators from six countries, Australia, Brazil, Europe, Japan, South Korea and Mexico. Respirators may also qualify for import under the EUA if the bear a CE mark, or are authorized by regulators in Australia, Canada or Japan.
However, in order to be authorized under the EUA, manufacturers and importers must first submit a request to FDA and demonstrate that their respirators meet the criteria laid out in the EUA.
FDA also invites companies to submit a separate EUA request if they would like to import non-NIOSH approved respirators that do not meet the criteria laid out in the EUA.
In recent weeks, FDA has also issued enforcement discretion policies for certain products, such as ventilators and remote monitoring devices. For any products being imported subject to an enforcement discretion policy, FDA says importers should use an Intended Use Code of 081.006: Enforcement discretion per final guidance, along with the appropriate product code for the device.


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