FDA Form 2877: When Radiation-Emitting Imports Need It

FDA Form 2877 is the importer’s declaration for electronic products that emit radiation and are subject to a federal performance standard. Two opposite mistakes cause most of the trouble at entry. Some importers file a 2877 declaration for every electronic product with a light or a power supply, which invites questions FDA did not need to ask. Others assume a CE mark or a foreign test report replaces the US requirement, and ship lasers or microwave ovens without the accession number FDA expects to see.

The rule is narrower and stricter than either assumption. A 2877 declaration applies only to products covered by a performance standard in 21 CFR 1020 to 1040, and for those products the entry has to carry the right declaration code and, in the common case, a valid accession number tied to the right manufacturer. This guide covers which products trigger the form, how the declaration codes work in ACE, what to collect from the foreign manufacturer, and how holds on radiation-emitting products play out.

When Form 2877 Applies and When It Does Not

FDA regulates radiation-emitting electronic products under Chapter V, Subchapter C of the Federal Food, Drug, and Cosmetic Act. The general requirements sit in 21 CFR 1000 to 1005 and apply broadly, including the duty to deal with defects. Performance standards are a smaller set of product-specific rules in 21 CFR 1020 to 1040, and Form FDA 2877 is required only for products that one of those standards covers.

That distinction settles most questions. A laser level, a microwave oven or a cabinet X-ray unit is under a standard, so the importer declares compliance. An LED bulb, most LED face masks and most UV-C germicidal lamps are not covered by any 2877 standard, so no declaration is filed for them, although the general radiation-safety and defect obligations still apply. The list of standards has also shrunk: a January 20, 2023 final rule (88 FR 3638) repealed or amended several standards, and Part 1050 on ultrasonic therapy products no longer appears in the eCFR.

A CE mark does not substitute for any of this. European conformity marking has no standing at a US port, and a laser product that meets IEC 60825-1 still needs to be reported to FDA and declared at entry. FDA’s Laser Notice 56 sets the conditions under which conformance with IEC 60825-1 is accepted in place of parts of the US laser standard, and FDA has not published any final rule amending the laser standard in 21 CFR 1040 since then.

Laser, LED, UV and Microwave Products Under the Performance Standards

The table maps the standards to the product categories importers see most often. Where a product combines functions, such as a projector with a laser light source or a beauty device built around a laser, the standard follows the radiation source, not the retail category.

Products that are also medical devices

Diagnostic X-ray equipment and lasers intended for medical use are both radiation-emitting products and medical devices. FDA’s ACE guidance requires them to meet both sets of data requirements: the device registration, listing and premarket data, and the radiation declaration. Importers that already handle device entries as an FDA initial importer still need the 2877 layer on these lines.

Declaration Codes RA, RB, RC and RD in ACE

At entry, Form FDA 2877 declarations are transmitted electronically as Affirmation of Compliance codes in the FDA message set, under the radiation program (RAD) with processing code REP for non-medical products, or under the device program with processing code RED for radiation-emitting medical devices. FDA’s ACE Affirmation of Compliance list dated March 10, 2026 is the current reference, and only one radiation declaration is allowed per entry line.

The declaration families work as follows. The RB group is used for products declared in compliance with their standard, and RB1 is the code that carries the accession number. The RA group covers the recognized exceptions, such as products made before the standard took effect, components, small quantities of household goods and test units. The RC and RD groups cover noncompliant products. RC codes are for products that will not be brought into compliance: RC1 for research, investigations or training, which requires an approved Form FDA 766 and a temporary importation bond, and RC2 for trade shows, which requires a temporary importation bond but no Form 766. RD codes are for products being brought into compliance while held intact in a bonded warehouse under a temporary importation bond: RD1 when Form FDA 766 is already approved, RD2 when it is submitted with the entry, and RD3 when it will be submitted within 60 days.

Where RB1 entries fail

A frequent rejection is an RB1 line sent without an accession number, or with one that belongs to a different manufacturer. RB1 has to travel with the ACC code (product report accession number) or the ANC code (annual report accession number), and the manufacturer declared on the line has to match the manufacturer on the report FDA holds. Trading companies that sell factory output under their own name can create this mismatch without noticing it. A licensed customs broker catches it before transmission only if the accession data is collected with the purchase order.

Accession Numbers: What the Foreign Manufacturer Must Supply

Under 21 CFR 1002.10, the manufacturer of a product subject to a standard submits a product report to FDA before the product is introduced into commerce. FDA assigns an accession number to the report, and that number is what the RB1 declaration points to. The importer cannot generate one; it has to come from the manufacturer that filed the report.

Foreign manufacturers of electronic products carry a second obligation. Under 21 CFR 1005.25, each must designate a permanent US resident as its agent for service of process before offering products for import. The agent is separate from any device-side US Agent and from the importer of record, though one company can hold more than one role.

For each radiation-emitting SKU, the document pack collected before booking should contain:

• The applicable standard (for example 1040.10 for a laser product) and the product’s classification under it.
• The accession number of the product report or annual report, and the exact manufacturer name on that report.
• Model numbers covered by the report, matched to the commercial invoice.
• Confirmation that the 1005.25 agent designation is in place.
• For medical lasers or X-ray equipment, the device registration, listing and premarket data as well.

Holds and Refusals for Radiation-Emitting Products

FDA screens radiation-emitting products through the same entry review as other regulated goods. A line with a valid declaration and a matching accession number can be released as May Proceed; a line with missing or inconsistent data is routed to review, and a product that appears not to comply can be detained.

Import alerts shape the risk by product type. Import Alert 95-04 covers laser pointers, laser levels, laser gunsights, laser light show projectors and similar laser products from firms on its Red List, and allows detention without physical examination. Import Alert 95-01 covers sunlamps, and Import Alert 95-05 covers noncertified electronic products.

A detained product that can be fixed goes through Form FDA 766, the application to bring it into compliance, backed by a bond with a redelivery condition. The importer pays for FDA supervision of the work, charged at 267% of the GS-11/4 hourly rate with a one-hour minimum. Where the goods need to stay under customs control, entry into a customs bonded warehouse is part of the RD route. A product that cannot be brought into compliance is refused and must be exported or destroyed under supervision within 90 days of the refusal notice.

The bond exposure is real. CBP can demand redelivery of noncompliant goods (19 CFR 141.113(c) for radiation-emitting medical devices, 141.113(d) for other electronic products), and failure to redeliver triggers liquidated damages of up to three times the value of restricted merchandise under 19 CFR 141.113(i). The right customs bond structure matters for any importer with regular radiation-emitting lines.

Building a 2877 Check Into the Purchase Order

Most 2877 problems are created months before arrival, when a buyer approves a factory sample without asking whether the product sits under a standard. Moving the check upstream costs little and removes the most frequent causes of hold.

How CargoTrans supports radiation-emitting imports

CargoTrans classifies products against the standards, collects accession data from foreign manufacturers, transmits the declarations and manages Form 766 and bond requirements when a product needs reconditioning. The work sits within our trade compliance management service. For products that face outright restrictions rather than a declaration, see our guide to prohibited and restricted imports.

• At sourcing: classify each new electronic SKU against the performance standards and flag every laser, microwave, X-ray, sunlamp or mercury vapor lamp product.
• At PO: require the accession number, report holder name and 1005.25 agent from the factory as a contract deliverable.
• Before booking: match models, manufacturer name and accession number to the commercial invoice, and screen the supplier against Import Alerts 95-01, 95-04 and 95-05.
• At entry: transmit a single radiation declaration per line, RB1 with ACC or ANC for compliant goods, the correct RA code for an exception.
• After entry: retain the signed 2877 declaration with the entry records for five years.

Frequently Asked Questions