To fill out FDA Form 2877, you confirm the product is covered by a radiation performance standard in 21 CFR Parts 1020 through 1050, enter the customs entry and manufacturer details, choose one of four declaration codes (A, B, C, or D), and have your customs broker transmit the data through the Automated Commercial Environment when the entry is filed. There is no paper submission. The form itself is a declaration of compliance, so the accuracy of what you put on it matters more than the mechanics of typing it in.
First, Confirm the Form Actually Applies
Form 2877 is only required for electronic products that fall under a specific FDA radiation performance standard. If no standard covers your product, you don’t file the form at all. Filing one anyway invites scrutiny you don’t need; skipping one when it was required gets your shipment flagged.
The product categories with active performance standards are:
- Television receivers (21 CFR 1020.10)
- Cold-cathode gas discharge tubes (21 CFR 1020.20)
- Diagnostic X-ray systems and components, including radiographic, fluoroscopic, and computed tomography equipment (21 CFR 1020.30–1020.33)
- Cabinet X-ray systems such as baggage inspection machines (21 CFR 1020.40)
- Microwave ovens (21 CFR 1030.10)
- Laser products, from Class I pointers to Class IV industrial lasers (21 CFR 1040.10 and 1040.11)
- Sunlamp products and ultraviolet lamps (21 CFR 1040.20)
- Mercury vapor lamps (21 CFR 1040.30)
The regulatory definition of electronic product radiation in 21 CFR 1000.3 is broad, but breadth of definition doesn’t create a filing obligation. A Bluetooth speaker emits radiofrequency energy and still needs no Form 2877, because no performance standard in Parts 1020–1050 applies to it. The only question is whether your specific product falls under one of the standards listed above.
Get the Manufacturer’s Accession Number First
Before you can declare compliance on Form 2877, the manufacturer needs to have submitted a product report to the FDA’s Center for Devices and Radiological Health under 21 CFR 1002. Table 1 in 21 CFR 1002.1 spells out which report types apply to each product category, including initial, supplemental, abbreviated, and annual reports.
When the CDRH Document Control Center receives that report, it assigns a unique accession number and sends an acknowledgment letter, typically within about four weeks. That accession number is what you’ll enter on Form 2877 to show the manufacturer has already reported the product. If your overseas manufacturer hasn’t filed a product report, you have no accession number to enter and no basis for a compliance declaration.
Manufacturers can submit reports by email in PDF to RadHealthCustomerService@fda.hhs.gov, through the free FDA eSubmitter software, or by mail to the CDRH Document Control Center at 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002. When you’re bringing in a product from a new manufacturer for the first time, build at least a month of lead time into your schedule for the report and the accession number.
Filling In the Entry and Manufacturer Fields
You can download the current form from the FDA at https://www.fda.gov/media/72236/download. The submission itself goes through ACE, but the PDF is the clearest way to see every field your broker has to populate.
The top section captures the customs entry: the entry number assigned by U.S. Customs and Border Protection, the port of entry, and the date of entry. Below that, enter the full legal name and physical address of the manufacturing facility. This has to match what the manufacturer submitted in its product report to the FDA. A mismatch between the manufacturer name on the form and the name in FDA records is one of the more common reasons entries get pulled for manual review.
Then identify the product by brand name and model number, and cite the applicable performance standard (for example, 21 CFR 1030.10 for a microwave oven). Include the FDA accession number from the manufacturer’s product report.
Choosing the Right Declaration Code
The center of the form is a single choice among four declaration codes. Picking the wrong one can hold your shipment or draw enforcement action.
Declaration A is for products not subject to a radiation performance standard. It applies when the product meets one of seven listed conditions, such as being manufactured before the relevant standard took effect or falling in a category no standard covers. In effect, this declaration tells the FDA that the form is being filed out of caution but no standard governs the product.
Declaration B is for products that are subject to a performance standard and fully comply. This is the routine declaration for commercial imports of consumer electronics, medical devices, and industrial equipment carrying a manufacturer’s certification label. You need the accession number to support it.
Declaration C is for products that don’t comply and are being imported under a temporary import bond. The product cannot enter U.S. commerce; it is used under a radiation protection plan and then destroyed or exported under CBP supervision. This is typical for research, testing, or training use.
Declaration D is for noncompliant products being imported under bond for reconditioning or modification to bring them into compliance. The product stays under bond and cannot enter commerce until the FDA confirms that an approved petition to bring the product into compliance has been satisfied.
Declaration B covers the bulk of commercial imports. Declarations C and D both require a CBP bond, and the product stays under that bond until it’s exported, destroyed, or brought into compliance. Expect closer FDA attention and follow-up documentation requests on C and D filings.
Submitting Through ACE
Form 2877 data is transmitted electronically through the Automated Commercial Environment at the time your entry is filed with CBP. Under 21 CFR 1.77, an ACE filer must submit all declarations required by the form electronically for products subject to standards under Parts 1020–1050. Most importers work through a licensed customs broker, who maps the form’s fields into the correct ACE data elements during entry filing.
There is no separate paper filing with the FDA. The ACE data feeds directly into FDA import screening, so accurate entry at this stage matters. Before your broker transmits, verify that the manufacturer name, accession number, model number, and declaration code all match your supporting documents. Fixes after transmission cost time your goods will spend sitting at the port.
If the Entry Gets Flagged or Detained
Once submitted, the entry is screened against the FDA’s databases. Clean entries can receive a “May Proceed,” which releases the goods from the port. A May Proceed doesn’t foreclose future FDA action if a problem surfaces later, but for practical purposes the shipment moves.
Flagged entries go to a field examiner for manual review. Common triggers include a missing or unrecognized accession number, a manufacturer name that doesn’t match FDA records, or an incomplete declaration. The examiner may ask for test reports, certification labels, or technical manuals. Answer quickly. Slow responses can escalate a review into a formal detention.
A formal detention comes with a Notice of Detention and Hearing. It gives you a chance to show that the product complies or to propose how to bring it into compliance. The notice states the response deadline, typically 20 calendar days. Your response, called testimony in FDA process, can include test data, corrected documentation, or an application to relabel or recondition using Form FDA 766. Submit through the Import Trade Auxiliary Communication System (ITACS), or contact the local import division by email, fax, or mail. A designated representative can respond in your place with written authorization.
If you need more time, request an extension before the deadline expires and give a reasonable basis for it. A granted extension arrives as a new Notice of FDA Action with a revised date.
Missing the deadline, or submitting a weak response, lets the compliance officer refuse admission. A refused product must be exported or destroyed under CBP supervision at the importer’s cost, and the refusal stays on record with the FDA, which can raise scrutiny on later shipments. For Declaration C and D imports, the bond posted at entry covers these outcomes, and losing the bond on top of the goods makes the loss meaningful.