Medical Devices Archives | Customs & International Trade Law Blog

FDA Announces One-Day Inspection Pilot

The U.S. Food and Drug Administration (FDA) announced that it is piloting one-day inspectional assessments. These assessments will be shorter, more focused, and will complement existing standard FDA inspections.

Shorter Inspections, More Coverage

Launched in April 2026, the pilot is part of a broader initiative to make the agency’s inspectional resources more targeted and efficient. The new assessments will allow for broader coverage, enabling the agency to assess more facilities without compromising regulatory rigor.

The pilot is being conducted across multiple FDA inspectorates, including human and animal foods, biologics, medical products, and clinical research programs. Facilities are selected using risk-based criteria such as:

Product type
Prior inspection outcomes
Operational characteristics

As of late April 2026, the FDA has completed approximately 46 one-day assessments.

The agency made clear that one-day inspectional assessments are not intended to replace standard FDA inspections. Instead, they are meant to provide an additional tool to the agency’s enforcement approach. The ‘one-day’ framework is also flexible – investigators retain authority to expand the scope or duration of an assessment if warranted.

The pilot will continue through fiscal year 2026. The FDA is currently developing evaluation metrics to assess effectiveness, including inspection duration, escalation rates, and the utility of findings in informing risk-based decision-making.

What Facility Owners and Operators Should Do

Facility owners and operators should remain ready […]

By Jennifer Diaz|2026-05-26T12:37:23-04:00May 26, 2026|Best Practices, Cosmetics, Enforcement, Food, Import, Medical Devices, U.S. Food and Drug Administration (FDA)|Comments Off

FDA Finalizes New National Drug Code Format

On March 5, 2026, the Food and Drug Administration (FDA) published a Final Rule adopting a new format for the National Drug Code (NDC). The rule takes effect on March 7, 2033. On the effective date, the FDA will assign new 12-digit NDCs and convert all previously assigned 10-digit NDCs to the uniform 12-digit NDC format.

What is the NDC?

The NDC is an FDA standard for uniquely identifying drugs marketed in the U.S. Currently, the NDC assigned by the FDA for each listed drug marketed in the U.S. is a unique 10-digit number and can be in several different formats.

Current formats:

10-digit identifier

The FDA’s standard NDC is a 10-digit numerical identifier that includes a labeler code, product code, and package code.

There are 3 FDA-assigned formats for the standard NDC:

4-4-2
5-3-2
5-4-1

HIPAA Format

The Health Insurance Portability and Accountability Act (HIPAA) adopted a uniform 11-digit NDC format that must be used when a HIPAA-covered transaction includes an NDC. This 11-digit format is standardized into a 5-4-2 format and created by adding a leading zero to either the labeler, product, or package code.

Upcoming 6-Digit Format

The FDA will run out of 5-digit labeler codes in 10-15 years. Per FDA regulations (21 CFR 207.33), once the FDA runs out of 5-digit labeler codes, it will start assigning 6-digit labeler codes. Without this proposed change, there would be five NDC formats, 3 in 10- […]

By Jennifer Diaz|2026-03-05T10:07:19-05:00March 5, 2026|Enforcement, Food, Import, Medical Devices, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|Comments Off

ICYMI: FDA Launches Nationalized Entry Review Program (NER)

FDA recently implemented the Nationalized Entry Review Program (NER), which centralizes how the agency reviews imports nationwide. The program is effective as of August 4, 2025. Key changes include:

Coordinated National Response: Rather than each port conducting manual reviews of certain entries on its own, specialized teams now coordinate their efforts across the country to more quickly identify and stop dangerous products.
Harmonized Real-Time Alert System: If the FDA detects a high-risk product at one port, such as contaminated infant formula or counterfeit drugs, alerts are immediately shared across all ports so they can watch for the same threats.
Improved Efficiency: Built on a successful 2022 pilot, the NER program has sped up processing by 70% and increased detection of high-risk products by 36%.
Expanded Reviewer Capacity: The program allows for more FDA reviewer availability and collaboration across the national network.

The FDA’s current evaluative standards, regulatory requirements, and admissibility thresholds remain the same.

The FDA has also published a communications guide that includes general contact protocols, hot shipments handling, email formatting requirements, and FAQs.

Diaz Trade Law provides assistance with FDA pre-compliance as well as assistance in successfully navigating FDA enforcement actions. For assistance with NER requirements or other FDA matters, contact us […]

By Jennifer Diaz|2025-09-12T09:42:51-04:00September 12, 2025|Cosmetics, Enforcement, Food, Import, International Trade, Medical Devices, Pre-compliance, U.S. Food and Drug Administration (FDA)|Comments Off

Customs and Trade Law Weekly Snapshot

Here is a recap of the latest customs and international trade law news:

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By Jennifer Diaz|2022-08-19T08:51:19-04:00August 19, 2022|International Trade, Medical Devices, U.S. Customs and Border Protection (CBP), U.S. Department of Commerce (DOC), U.S. Federal Trade Commission (FTC), U.S. Food and Drug Administration (FDA), U.S. Office of Foreign Assets Control (OFAC)|2 Comments

Draft Guidance on Medical Device Transition Period

In response to the COVID-19 Pandemic, the FDA took unprecedented action in transforming its enforcement because of the declaration of a Public Health Emergency while also issuing, and continuing, Emergency Use Authorizations. These governmental actions facilitated and increased the importation of necessary medical devices needed to combat the pandemic here in the United States. And now as the U.S. relaxes its pandemic protocol, the FDA is exploring the best way to have medical devices transition back to pre-pandemic regulations and protocol. On December 23, 2021, the FDA issued two draft guidance documents in the Federal Register detailing its proposed medical device transition plans for all medical devices previously imported under the two aforementioned government declarations. And to provide further assistance, the FDA hosted a webinar “Draft Guidances on Transition Plans for COVID-19 Related Medical Devices” providing further explanations to the trade community on what can be expected from the proposed transition plans.

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By Jennifer Diaz|2022-03-10T11:56:55-05:00March 15, 2022|COVID-19, Import, Medical Devices, PPE, U.S. Food and Drug Administration (FDA)|Comments Off

Don’t Let FDA Target Your Medical Device Company

Did you know FDA has issued 1,569 enforcement actions against medical device companies? Now is the time to ensure your medical devices are in compliance with FDA laws and regulations prior to importation. If your business is manufacturing, repackaging, relabeling, and/or importing medical devices into the U.S., or wants to start, our one-hour webinar on “Importing Medical Devices in Compliance with U.S. FDA” is for you. We will provide TOP tips to avoid U.S. Food and Drug Administration (FDA) enforcement action, and best practices to navigate and mitigate FDA enforcement.

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By Jennifer Diaz|2021-10-07T14:48:15-04:00August 10, 2021|COVID-19, Import, Import Alert, International Business, International Law, International Trade, Labeling, Medical Devices, PPE, Pre-compliance, Speaking, U.S. Food and Drug Administration (FDA)|Comments Off

Don’t be a Target, Learn Best Practices to Mitigate FDA Enforcement

The U.S. Food and Drug Administration (FDA) is in full enforcement mode issuing 260 warning letters in 2021 alone! Now is the time to ensure your products are in compliance with the Federal Food, Drug, and Cosmetic Act (the Act) prior to importation. Manufacturers, importers, distributors, and others engaged in the production or sale of over the counter (OTC) drugs or cosmetic products must be aware of FDA’s various enforcement mechanisms, and more importantly, how to avoid and/or mitigate such actions. FDA’s most common enforcement activities include notices of FDA action, warning letters, seizures, voluntary recalls, injunctions, and criminal prosecution.

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By Jennifer Diaz|2021-07-22T11:27:59-04:00May 27, 2021|Cosmetics, E-Cigarette, Food, FSMA, Gluten Free, Import, Import Alert, International Trade, Medical Devices, Pre-compliance, Reasonable Care, Tobacco, U.S. Food and Drug Administration (FDA)|Comments Off

A Year in Review!

2020 has been a difficult year filled with immense challenge and change (to say the least). From all of us at Diaz Trade Law, we are incredibly thankful and grateful for your support. Despite a pandemic, Diaz Trade Law still managed to save our clients MILLIONS of dollars in 2020. It is with great joy that we finish off 2020 filled with numerous achievements and accomplishments. We look forward to assisting you in what we envision will be a better and brighter 2021!

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By Jennifer Diaz|2021-10-12T15:14:54-04:00December 23, 2020|301 INVESTIGATIONS, Best Practices, China, China Trade War, Counterfeits, Cuba, Currency Seizure, Customs Expert, Enforcement, Export, Forced Labor, Import, Import Alert, International Business, International Law, International Trade, International Travel, IPR, Trademarks and Logos, Medical Devices, U.S. Customs and Border Protection (CBP)|Comments Off

Did You Know That Sunglasses Are Regulated by The FDA As Medical Devices?

Whether you import sunglasses into the United States or sell sunglasses in the U.S. commerce, you are required to comply with the laws and regulations of the U.S. Food & Drug Administration (FDA). The FDA regulates sunglasses products to ensure their safety and impact resistance. These products are regulated as medical devices as they are intended to mitigate or prevent the effect of the sun’s ultraviolet (UV) rays on the eyes of a person. The term “Medical Device” is defined in 21 CFR 201(h).

The following are FDA regulations that apply sunglasses. Failure to comply with them may result in CBP and FDA detaining your sunglasses at the U.S. port of entry.

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