FDA Form 2877: Declarations A-D Explained

General information about a federal import form. It is not customs, legal or product-classification advice.

Short answer

FDA Form 2877 is the declaration an importer or customs broker completes for electronic products subject to FDA radiation control standards (21 CFR 1010 and 1020-1050) before those products enter the United States. The importer selects one of four declarations: A (not subject to a performance standard), B (complies), C (does not comply; research, demonstration or training under bond) or D (does not comply; to be brought into compliance). It is a declaration, not a clearance or approval. Source: FDA Form 2877, edition 7/26, checked 2026-11-01.

Definition and scope

The form is titled “Declaration for Imported Electronic Products Subject to Radiation Control Standards.” According to its instructions, the local FDA district office reviews the declaration and tells the importer or agent whether the products may be released into U.S. commerce or must be held under bond until exported, destroyed or reconditioned. Until release, a shipment may be subject to redelivery for FDA examination. The form cites 21 U.S.C. 360mm, 21 CFR 1005 and 19 CFR 12.90-12.91 as references.

The form header shows OMB No. 0910-0025, expiration May 31, 2029, and a stated burden of 0.2 hour per response. The footer reads “FORM FDA 2877 (7/26)” and says the previous edition is obsolete, so copies hosted elsewhere may be out of date.

It covers electronic products that fall under the radiation control standards. It is separate from device premarket pathways such as 510(k): the form does not clear a product for sale. For background on one kind of radiation-emitting equipment, see what an X-ray machine is; for the manufacturer-side concept, see FDA-registered establishment.

How it is used in practice: paper and electronic entries

Paper entries

For paper entry documents, the form instructs the importer to send FDA two copies of the Customs entry form (for example CF 3461, CF 3461 Alt or CF 7501), one copy of Form FDA 2877 and the commercial invoice(s) in English. If the products are given a MAY PROCEED, a signed copy of CF 3461 is returned; otherwise FDA issues a Notice of Action.

Electronic entries

For entries filed through ACS/ABI, the form says to hold the FDA 2877 in the entry file and “do not submit to FDA unless requested.” The declaration is transmitted as an affirmation-of-compliance (AofC) code: RA#, RB#, RC# or RD# (the form’s example: Declaration A5 = RA5). The model number goes in AofC code MDL and the brand name in the FDA line-level brand name field. If RA3 or RA6 is selected, the quantity must also be transmitted. Multiple electronic entries of the same product and model families may be supported by one form dated not more than 12 months previously.

The four declarations compared

Declaration	What the importer states	What the form says follows
A (RA1-RA7)	Not subject to radiation performance standards, for one of seven listed reasons.	Importers “should be prepared to demonstrate” compliance or non-applicability. Components or sub-assemblies must be non-functioning.
B (RB1-RB2)	Complies with the performance standards applicable at the date of manufacture, with a certification label or tag on each product.	RB1 requires the FDA Establishment Identifier (FEI) of the manufacturer that filed the report; the report’s accession number goes in AofC code ACC. A photo of the certification label is “strongly recommended.”
C (RC1-RC2)	Does not comply; imported only for research, investigations/studies, demonstration or training.	Held under Temporary Import Bond or equivalent; disposition is export or destruction under Customs supervision. Form FDA 766 must be approved before use, except for trade shows and demonstrations.
D (RD1-RD3)	Does not comply; will be brought into compliance under an FDA-approved plan.	Held by the district office; Form FDA 766 required. Limited to occasional shipments: “ongoing reconditioning is considered manufacturing.” If the time frame lapses with no extension, entry is refused.

The seven Declaration A reasons

A1: manufactured before the effective date of any applicable standard (the date of manufacture is entered).
A2: excluded by the standard’s applicability clause or definition, or by FDA written guidance.
A3: personal household goods of an individual entering the U.S. or a returning U.S. resident; limit 3 of each product type.
A4: property of a party outside the U.S., returned after repair or servicing.
A5: components or subassemblies for manufacturing, or replacement parts. The form states this is not applicable to diagnostic X-ray parts.
A6: prototypes for ongoing product development, not distributed.
A7: reprocessed products labeled for export only; the form adds that reprocessed products must be exported by the importer without intermediate transfer of ownership.

Where it matters for labs and clinics

Labs and clinics that buy imported radiation-emitting equipment are usually not the party who completes the form, but the importer or broker will need the product facts it asks for. The table maps common situations to the declaration the form’s own wording points to. It restates the form; it does not decide how a specific product is classified.

Situation	Declaration the form wording points to	Detail from the form
Product whose manufacturer filed a radiation report	B1	Needs the manufacturer’s FEI and the report accession number; certification label on each product.
Unit made before the applicable standard took effect	A1	Date of manufacture must be given.
Equipment returned after repair or servicing abroad	A4	Property of a party outside the U.S.
Replacement parts or sub-assemblies	A5	Must be non-functioning; not applicable to diagnostic X-ray parts.
Non-compliant unit for research, evaluation, training or demonstration	C1 or C2	Trade-show units need dates and use restrictions and a visible sign that the product does not comply; medical products, cabinet X-ray and Class IIIb and IV lasers may not operate at trade shows.
Non-compliant unit the importer intends to bring into compliance	D1-D3	Approved petition attached, petition request attached, or request to be submitted within 60 days.

Information the form asks for

Port of entry, entry number and date of entry.
Manufacturing site name and address, and country of origin.
Importer and ultimate consignee, product description, quantity, model number(s) and brand name(s).
For Declaration B: the manufacturer’s FEI, the report accession number and, ideally, a photo of the certification label.
Signature of the importer of record, and the name and title of the responsible person.

The form warns that a false declaration can be fined up to $10,000 or imprisoned up to 5 years or both under 18 U.S.C. 1001, and that importing a non-compliant electronic product can bring civil penalties of $1,000 per violation, up to $300,000 for related violations, under 21 U.S.C. 360pp. Related safety topics on CASRAI: radiation survey meter checks and dosimetry badges.

Common misunderstandings

It is not an FDA approval. It is the importer’s declaration; the district office decides whether products may be released or held under bond.
It is not always sent to FDA. That is the paper-entry route. For electronic entries the form says to hold it in the entry file unless FDA requests it.
Older copies may be obsolete. The current FDA file is edition 7/26 and states that the previous edition is obsolete.
Declaration C and Form FDA 766 are not the same thing. Form FDA 766 is a separate form outlining protections. It is required for C except for trade shows and demonstrations, and for D it documents the plan to reach compliance.
Prototype imports have unit limits. FDA’s May 14, 1997 prototype guidance sets 50 units per entry for televisions, microwave ovens and inherent Class I laser products and 200 for other software-dependent laser products such as CD-ROM/DVD, and requires written control procedures. The form words its limits slightly differently (50 microwave ovens; 200 units for optical drives), so each source’s text applies as written.

FAQ

What is FDA Form 2877 used for?

It declares, before entry into the United States, whether imported electronic products subject to radiation control standards comply, are not subject to them, or are being imported for limited purposes under bond.