By Tam Nguyen | CEO, GOL Solution | 24+ years in international trade & cross-border logistics

Last Updated: October 2026

To clear an urgent FDA shipment, answer three questions on day one: which FDA rule applies to the product, which record FDA says is missing, and who can fix that record fastest. In the two urgent situations in this article, the bottleneck was a route or a record, not a failed product. That is why the answer was days or weeks instead of months.

We have handled this at scale twice. In 2020 and 2021, when Covid-19 cut the supply of medical protective gear, we helped more than 50 Vietnamese suppliers and manufacturers of masks, protective clothing and hand sanitizer meet FDA’s labeling and listing standards so they could export to the US. The turnaround was about 30 days per company, against the 6 to 9 months a standard 510(k) can take. In 2026, we resolved within 2 business days a hold on a shipment of protective clothing that was stopped at a US port because its FDA listing was incomplete.

This article explains what FDA allowed in 2020, what we did for those exporters, what has ended and when (one deadline falls on December 26, 2026), and the checklist we use when a shipment is on hold.

What does it mean to clear an urgent FDA shipment?

Clearing an urgent FDA shipment means getting a held shipment released, or getting a product legally ready to enter the US, on a deadline counted in days. For a medical device, FDA expects three things to be in place before entry: the manufacturer’s establishment is registered, each device is listed, and the product has a premarket route. That route is a cleared 510(k), an exemption, or, during the pandemic, one of FDA’s emergency flexibilities.

These requirements sit in 21 CFR Part 807, and FDA can refuse admission of a device that does not comply under section 801 of the Federal Food, Drug, and Cosmetic Act. A foreign manufacturer also needs a US Agent. Entries for devices are filed with the registration and listing numbers of the parties and products involved, so a gap in either record shows at the port.

A hold can mean FDA found a problem with the product, but it can also mean FDA could not match the shipment to a complete record. The two need very different fixes, and working out which one you have is the first job.

Why did the US need an urgent clearance route in 2020?

Covid-19 cut the global supply of masks, gowns and gloves just as hospitals needed far more of them. China, a major supplier, tightened exports of medical supplies. Under Announcement No. 5 of 2020, issued by China’s Ministry of Commerce, General Administration of Customs and National Medical Products Administration, exporters of medical masks and medical protective gowns, among other items, had to file a declaration from April 1, 2020 showing Chinese medical device registration and compliance with the importing country’s standards, and customs released the goods only after checking the registrations. On April 26, 2020, China eased the rule: products with only foreign certification or registration could be exported if the exporter declared compliance with the importing country’s standards (Notice No. 12 of 2020).

The normal US route did not fit the emergency. In our experience a 510(k) premarket notification could take 6 to 9 months to complete, and with test labs around the world swamped, the lab wait alone could reach 6 months.

FDA used two tools. An emergency use authorization (EUA), under section 564 of the FD&C Act, lets an unapproved product be marketed in an emergency if it meets stated conditions. An enforcement policy is FDA stating that it does not intend to enforce certain requirements, such as 510(k), for a product type that meets stated conditions. Which tool applied depended on the product.

Hand sanitizer deserves a note because it is often grouped with the EUA products. It was not an EUA. It is an over-the-counter (OTC) drug, and FDA handled it through enforcement discretion. The formulation figures in the table come from the March 2020 version of FDA’s guidance, which FDA later revised.

Labeling carried real weight. For face masks, face shields and gowns authorized under EUAs, advertising and promotional materials had to state that the product was not FDA cleared or approved, along with disclosures about the limits of the authorization.

How did we help 50+ Vietnamese manufacturers export in about 30 days?

We matched each company’s exact product to the FDA route that applied, then brought its label and FDA listing up to that route’s standard. For these companies the work took about 30 days each, compared with 6 to 9 months for a 510(k).

No two companies started from the same place, so the work followed the same four steps:

1. Identify the product and the route. A surgical gown, a non-surgical gown, a medical mask and an alcohol-based sanitizer each followed different conditions (see the table above).
2. Check the product against that route’s conditions, such as a gown’s barrier level or a sanitizer’s formulation.
3. Correct the label and promotional claims, including the statement that the product was not FDA cleared or approved where the route required it.
4. Complete the FDA registration and listing for the manufacturer and the product.

How did we resolve a held protective clothing shipment in 2 business days?

In 2026, a shipment of protective clothing was held at a US port because the product’s listing on FDA’s system was incomplete. We resolved the hold within 2 business days.

The pandemic flexibilities were gone by then, so the standard rules applied: a device must be registered and listed, and an incomplete listing is a gap that shows at entry. What made 2 business days possible was where the problem sat. It was in one record, the listing, and not in the product. A hold caused by a product that fails a standard, or one that lacks a required 510(k), would not move this fast.

The lesson has stayed the same since 2020. For a different kind of hold, see how FDA detained a supplement shipment for missing FSVP. The sooner someone who knows the requirements for the product sees the hold notice and the listing, the sooner the right record gets fixed.

What happened to the exporters after 2020, and what ends on December 26, 2026?

After the emergency, the exporters had two choices. Some stopped trading with the US, because the shortage that created the demand had passed. Others had built good contracts and converted their listing to a proper 510(k) listing so they could keep exporting.

FDA’s flexibilities ended in stages:

Who needs to act: the December 26, 2026 date matters if any product you export to the US still depends on a pandemic-era EUA. FDA’s March 2023 transition guidance says a manufacturer can keep marketing an EUA device after termination only if FDA accepted a marketing application, such as a 510(k), for review before the 180-day period ended. As of October 2026 that date is about 10 weeks away.

The HHS notice covers respiratory protective devices and medical devices as categories. It does not name masks, gowns or gloves, and FDA will publish separate notices ending the individual EUAs, so confirm the status of each product before you assume either way.

How do you clear an urgent FDA shipment? A day-one checklist

Start with the hold notice, then work through six checks in order. The order matters because each check rules out a cause before you spend time on the next one.

1. Collect the hold notice and entry details the same day: the product, the importer, the entry number, the port and the reason FDA gave.
2. Confirm the product code and class. Decide whether the product needs a 510(k), is exempt, or is regulated as something else, such as an OTC drug. See how FDA classifies medical devices.
3. Check the manufacturer’s FDA establishment registration and, for a foreign manufacturer, its US Agent.
4. Check that every device is listed, and that the listing is complete and matches the product on the invoice.
5. Check the label and promotional claims against the requirements for that product.
6. Check that the registration and listing numbers on the entry match the records.

Fix the gap, then reply to FDA with evidence of the fix. If the checks show that the product itself fails a requirement, stop treating the hold as paperwork and plan for testing or clearance.

When does this approach not apply?

Fast clearance works when the gap is in a route or a record. It does not fit every hold.

• The product fails a standard or lacks a required premarket route. A listing fix will not release a surgical gown that needs a 510(k) it does not have. Testing or clearance takes months, not days.
• You hoped to use an emergency route for a new product. FDA withdrew its COVID-19 device enforcement policies on November 7, 2023, and the device EUA declarations end on December 26, 2026.
• The manufacturer cannot provide the information. Speed depends on documents, labels and product details arriving quickly.
• The hold has another cause, such as drug quality. Alcohol-based hand sanitizer is an OTC drug. Since the temporary policies ended, manufacturers must meet the OTC monograph requirements and current good manufacturing practice (CGMP).

Frequently asked questions

Sources

• FDA: Revoked EUAs for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
• Federal Register: Termination of Three Declarations Authorizing Emergency Use of Medical Devices During the COVID-19 Pandemic (July 2, 2026)
• HHS: Secretary Kennedy Signs COVID-19 Emergency Use Authorization Declaration Terminations
• The FDA Law Blog: FDA Withdraws Temporary Hand Sanitizer Policies Effective December 31, 2021
• Haynes Boone: FDA Relaxes Policies on Hand Sanitizer Amid COVID-19
• ArentFox Schiff: FDA Issues Enforcement Policy for Gowns, Other Apparel, and Gloves
• McDermott Will & Schulte: FDA Issues Enforcement Policies for Face Masks and Respirators
• National Law Review: Navigating FDA Policies for PPE and Liability Protections
• Morgan Lewis: FDA Finalizes Framework for Transitioning From COVID-Related Medical Devices
• Goodwin: The Long Unwinding Road (April 2023)
• China Ministry of Commerce, General Administration of Customs and NMPA: Announcement No. 5 of 2020 on Ensuring the Orderly Export of Medical Supplies
• Bird & Bird: Are You Exporting or Importing Covid-Related PPE From China? (Notice No. 12 of 2020)
• ICAT Logistics: FDA Ends Emergency Use Authorizations for PPE (customs entry requirements)