By: Judy McMeekin, Pharm. D., Associate Commissioner for Regulatory Affairs

The U.S. Food and Drug Administration continues to use all the tools and flexibilities available to us as we partner with federal, state, and local agencies and public health officials across the country to fight the COVID-19. An essential part of the FDA’s job is to ensure the safety and security of the US supply of food and medical products.

Many medical products that our healthcare workers and hospitals need to fight COVID-19 come from overseas, making the work of the FDA’s Office of Regulatory Affairs (ORA) imperative to ensure that products transit as quickly as possible through the entry points.

Judy McMeekin, Acting Commissioner for Regulatory Affairs, FDA
Judy McMeekin, Pharm. D.

The FDA is facilitating the entry of imported personal protective equipment (PPE) and COVID-19 test kits as well as drugs and medical devices, which are needed to provide supportive care to sick and hospitalized patients. Many of these products are also essential for essential workers, such as grocery store employees, food manufacturers and caregivers, who also need PPE to perform their essential tasks safely. We’re making sure products get to their destination quickly so frontline healthcare workers and essential workers have the tools they need to protect themselves and ensure patients get the care they need.

ORA protects the supply chain in two equally critical ways: first, we help ensure that safe products arrive and second, that illegal, unsafe and fraudulent products do not enter the country. While ORA staff screen medical products entering our country, we also find and block the entry of fraudulent products that falsely claim to prevent, diagnose, treat, or cure COVID-19. For example, we have found fraudulent COVID-19 test kits in international mail facilities that have been declared as “water treatment”, which may lead users to mistakenly think that they are protected against the virus. virus when in fact they can unknowingly contract it and pass it on to others. .

Importing products for the US market can be a complex process involving multiple federal agencies. The FDA works closely with US Customs and Border Protection (CBP) to allow FDA-regulated products to enter the United States. ORA staff are responsible for ensuring that imported PPE and medical products needed to care for and treat patients with COVID-19 are screened and verified as quickly as possible. Technology risk classification tools and systems quickly clear shipments that comply with import regulations and have the appropriate documentation in place – in many cases, within minutes.

The FDA uses the PREDICT risk-grading technology tool on commercial shipments, which number in the thousands, to release packages with accurate documentation and shipment contents in minutes rather than days. Overall, the FDA reviews more than 45 million of these shipments each year. Smaller, non-commercial shipments often enter through United States international mail facilities and go through their own screening process.

FDA entry examiners prioritize and review items offered for import to verify that the shipment can be placed in the domestic market. In cases where the shipper does not provide proper documentation, FDA should contact the shipper, importer, broker, or other involved parties to ensure we have complete documentation. This process can cause delays, sometimes creating frustration for the recipient. However, the FDA wants to ensure that we have complete information to determine if the product complies with US laws and regulations before it enters domestic commerce. We also want to ensure that delays for legitimate shipments are avoided. To facilitate this, we urge importers to familiarize themselves with FDA instructions and to accurately and completely document the contents of the shipment. In order to minimize disruption during the import process, we provide guidance for importers. Industry is encouraged to use our special email inbox, [email protected], to quickly communicate with us to answer questions and resolve issues.

Currently, there is no evidence that food or food packaging is associated with the transmission of COVID-19. We have temporarily postponed physical inspections of FDA-regulated products manufactured overseas, but we are using other tools, such as wearable screening devices, risk ranking tools, trend analysis apps, database and more, to help ensure the safety of products imported into the United States – tools that have proven successful in the past.

Our import operations team performs some inspections remotely rather than at an importer’s place of business. This applies to Foreign Supplier Verification Program (FSVP) inspections for food and feed. The FDA rule for FSVP requires importers to perform certain risk-based activities to verify that their foreign supplier is producing the food according to US food safety standards. Prior to the COVID-19 outbreak, FSVP inspections were conducted onsite. At the beginning of April, we moved to temporarily carrying out these remote inspections. Our investigators contact importers subject to remote inspections to explain the remote inspection process and request electronic records; see the April 3 Constituents Update and March 2020 Guidance for more details. This adaptation helps us ensure the safety of imported FDA-regulated products during the COVID-19 public health emergency.

Facilitating access to safe food, medical products and PPE is and will remain crucial for the foreseeable future. I’m proud of the FDA as we rise to the challenge and quickly adapt our processes to deal with the pandemic. We are determined to emerge even better and stronger and will pursue all available avenues to protect public health during and beyond the COVID-19 pandemic.