What is a Section 337 exclusion order?

A Section 337 exclusion order is a legal directive issued by the U.S. International Trade Commission (ITC) that instructs U.S. Customs and Border Protection to block imports of products that infringe U.S. intellectual property rights, such as patents, trademarks, or copyrights. Unlike court injunctions, exclusion orders stop infringing products at the border regardless of who imports them.

Can I still import photodynamic therapy devices after this ruling?

Yes, but only if your devices are not manufactured by or for the named respondents in the ITC case, and they don't infringe the patents at issue. You must ensure your supplier can provide documentation that their products either use non-infringing technology or are licensed under the relevant patents. Products that violate the exclusion order will be detained and potentially destroyed by CBP.

How do I know if my supplier is a named respondent?

Review the full Federal Register notice (publication number 2026-09243) available at federalregister.gov, which lists all respondents subject to the cease and desist orders. You can also check the ITC's Electronic Document Information System (EDIS) for the complete investigation file. Contact your supplier directly to ask if they were named in ITC Investigation No. [investigation number].

What happens if CBP detains my shipment under this exclusion order?

CBP will issue a detention notice giving you 30 days to prove your products aren't subject to the exclusion order (for example, by showing they're from a non-infringing manufacturer). If you can't provide satisfactory evidence, CBP will seize and may destroy the products. You won't receive a refund from your supplier unless your purchase contract includes protections for regulatory seizures. Contact a customs attorney immediately if you receive a detention notice.

Does this exclusion order have an expiration date?

No. Section 337 exclusion orders remain in effect indefinitely unless overturned on appeal, modified by the ITC in an enforcement proceeding, or vetoed by the President (which occurs in less than 1% of cases). The order continues even after the patents expire in most cases, though respondents can petition the ITC for modification based on changed circumstances.

ITC Bans Photodynamic Therapy Devices from Import

The U.S. International Trade Commission (ITC) has issued a limited exclusion order banning the import of certain photodynamic therapy (PDT) systems and components that violate U.S. patent rights—a decision that immediately affects medical device importers and could signal tighter enforcement of intellectual property in healthcare technology imports.

What Changed: ITC Bans Infringing PDT Device Imports

On May 11, 2026, the ITC concluded its Section 337 investigation by finding that certain photodynamic therapy systems, their components, and pharmaceutical products used with these systems infringe U.S. patents. The Commission issued a limited exclusion order (LEO) prohibiting entry of these devices when manufactured, imported by, or on behalf of the named respondents, along with cease and desist orders (CDOs) against all respondents in the case [Federal Register, 2026].

This means U.S. Customs and Border Protection (CBP) will now detain and potentially seize these products at the border if they're manufactured by or imported for the respondents named in the ITC's order.

What Is a Section 337 Investigation?

Section 337 of the Tariff Act (19 U.S.C. § 1337) allows U.S. companies to petition the ITC to block imports that infringe U.S. intellectual property rights—including patents, trademarks, or copyrights. Unlike federal court litigation, Section 337 investigations can result in border enforcement that stops infringing products from entering U.S. commerce entirely. These investigations typically take 12-18 months and conclude with either exclusion orders (blocking imports) or settlements [USITC, 2025].

Which Products Are Affected?

The exclusion order covers:

Photodynamic therapy systems (medical devices that use light-activated drugs to treat conditions like certain cancers and skin disorders)
Components of PDT systems (including light sources, fiber optic delivery devices, and control systems)
Pharmaceutical products specifically formulated for use with these PDT systems (photosensitizing agents)
Products containing these components assembled into larger medical devices

Who Are the Named Respondents?

The Federal Register notice indicates the order applies to products "manufactured by or on behalf of, or imported by or on behalf of, the respondents." While the specific company names aren't included in this summary, the official Federal Register notice will list all respondents subject to the CDOs. Importers should review the full ITC opinion (available through the ITC's Electronic Document Information System) to identify affected manufacturers.

Country Impact

Section 337 exclusion orders are country-neutral—they apply regardless of where the infringing products are manufactured. However, most medical device imports affected by recent Section 337 cases have originated from China, India, and other Asia-Pacific manufacturing hubs [USITC Trade Data, 2025].

What This Means for Small Business Importers

Immediate Impact: Border Detention Risk

If you import photodynamic therapy equipment or components, CBP officers at ports of entry now have instructions to detain shipments matching the description in the LEO if they're connected to the named respondents. Detention can last 30 days or longer while CBP investigates whether the products are subject to the exclusion order [19 CFR § 151.16].

Cost implications:

Demurrage fees for containers held at port (typically $75-$150 per day)
Storage fees at customs warehouses
Potential product seizure and destruction
Loss of customer relationships due to delivery delays

Supply Chain Disruption

Medical device distributors, clinics purchasing PDT equipment, and pharmaceutical wholesalers handling photosensitizing drugs may face:

Suspended shipments from affected suppliers
Inventory shortages if current suppliers are respondents
Contract breaches if you can't fulfill orders due to detained imports

Due Diligence Requirements

Going forward, importers of PDT devices must:

Verify supplier identity against the list of respondents in the ITC order
Request IP compliance certifications from manufacturers
Maintain documentation showing your products don't infringe the patents at issue
Consider alternative suppliers if current sources are named respondents

What Importers Should Do Right Now

1. Check Your Current Inventory and Shipments

Action items:

Review purchase orders and shipping documents for the past 90 days
Identify any PDT systems, components, or pharmaceutical products in transit
Cross-reference your suppliers against the respondent list in the Federal Register notice (publication number 2026-09243)

If you have shipments en route from named respondents, contact your customs broker immediately to assess detention risk.

2. Contact Your Suppliers

Questions to ask your manufacturers:

Were you named as a respondent in ITC Investigation No. [investigation number]?
Do your PDT products use alternative technology that doesn't infringe the patents?
Can you provide a legal opinion from U.S. patent counsel confirming non-infringement?
Will you indemnify me against CBP seizures or ITC enforcement?

Reputable suppliers should be able to answer these questions within 48-72 hours.

3. Review Your HTS Classification

Photodynamic therapy devices typically enter under Harmonized Tariff Schedule (HTS) codes in Chapter 90 (optical, medical, or surgical instruments):

9018.19.95 - Other electro-medical apparatus
9018.90.75 - Electro-diagnostic apparatus for functional exploratory examination

If you've been classifying these products under different codes, work with a licensed customs broker to ensure accurate classification—especially since CBP will now scrutinize PDT imports more closely.

4. Assess Alternative Suppliers

If your current supplier is a named respondent, begin qualifying alternative sources immediately. Consider:

U.S. domestic manufacturers (not subject to the exclusion order)
Non-infringing foreign manufacturers with documented IP compliance
Licensed suppliers who have patent licenses from the original complainant

Qualifying new medical device suppliers typically takes 60-90 days due to FDA registration and quality system requirements.

5. Consult Legal and Customs Professionals

When to seek professional help:

If you've imported from named respondents within the past 6 months
If you have significant inventory that might be subject to the CDO
If you're unsure whether your products fall within the exclusion order's scope
If CBP detains your shipment

A licensed customs broker can help navigate CBP detention procedures, while a customs attorney can advise on challenging the applicability of the exclusion order to your specific products.

Timeline and Enforcement

Immediate Enforcement

The limited exclusion order and cease and desist orders are effective immediately as of the Federal Register publication date (May 11, 2026). CBP begins enforcement as soon as it receives the order, typically within 24-48 hours [ITC Practice and Procedure, 2025].

No Grace Period

Unlike tariff changes that sometimes include delayed implementation, Section 337 exclusion orders take effect immediately with no transition period. Any covered products arriving after May 11, 2026, are subject to detention.

Investigation Conclusion

The ITC investigation is now terminated. The exclusion order remains in effect indefinitely unless:

Successfully appealed to the Federal Circuit Court of Appeals (must be filed within 60 days)
Modified by the ITC in a subsequent enforcement proceeding
Overridden by Presidential veto (rare; must occur within 60 days)

Presidential Review Period

The President has 60 days from the ITC's decision to veto the exclusion order for policy reasons. Based on historical data, Presidential vetoes occur in fewer than 1% of Section 337 cases [USITC Data, 2024]. Importers should not rely on a potential veto when making supply chain decisions.

Broader Implications: Section 337 Trend in Medical Devices

This case reflects a growing trend of intellectual property enforcement through Section 337 investigations in the medical device sector. In 2025, the ITC instituted 14 investigations involving medical or pharmaceutical products—a 40% increase from 2023 [USITC Annual Report, 2025].

Why medical devices are targets:

High patent density in medical technology
Significant profit margins justify legal costs
Fast-growing imports from Asia-Pacific markets
FDA approval doesn't guarantee patent freedom-to-operate

Importers in adjacent medical device categories (surgical instruments, diagnostic equipment, therapeutic devices) should proactively review their supply chains for potential IP risks.

How TariffCenter.AI Can Help

Navigating Section 337 exclusion orders requires understanding:

Which HTS codes are affected
Whether your suppliers are named respondents
What alternative compliance strategies exist
How to document non-infringement for CBP

TariffCenter.AI's Section 337 Tracker monitors active ITC investigations and exclusion orders, cross-referencing them with your imported products' HTS codes and supplier information. Our AI-powered platform:

✓ Alerts you immediately when new exclusion orders affect your product categories
✓ Identifies alternative suppliers not subject to ITC orders
✓ Tracks Presidential review periods and appeal deadlines
✓ Generates compliance documentation for CBP review

Check your exposure now → Enter your HTS codes or product descriptions to see if this or other Section 337 orders affect your imports.

Disclaimer

This article provides general information about ITC Section 337 enforcement and is not legal advice. Section 337 cases involve complex patent law and customs procedures. Importers potentially affected by this exclusion order should consult a licensed customs attorney. Tariff rates, classifications, and enforcement priorities change frequently—verify current requirements with U.S. Customs and Border Protection or a licensed customs broker before making import decisions.