FDA Form 2877 — "Declaration for Imported Electronic Products Subject to Radiation Control Standards" — is the FDA declaration required at import for any electronic product that emits radiation, even if the radiation emission is unintentional. The form is filed by the importer (or customs broker) with the Entry Summary for products under FDA jurisdiction at 21 CFR Parts 1000–1050.
Products requiring Form 2877 include:
- Diagnostic X-ray equipment and components
- Microwave ovens
- Laser products (laser pointers, surgical lasers, level lasers, barcode scanners)
- Ultrasound therapy and diagnostic equipment
- Cabinet X-ray systems
- Sunlamps and tanning beds
- Mercury vapor and high-intensity discharge lamps
- CRT monitors and televisions (legacy)
- LED products in certain categories
- Cell phones and other RF-emitting devices in specific circumstances
The form requires the importer to declare one of five declarations (A through E):
- A — Product complies with all applicable FDA performance standards
- B — Product is exempt (research, U.S. government, parts, etc.)
- C — Product is not subject to performance standards
- D — Product does not meet standards but is being modified to comply
- E — Product is being imported for repair or refurbishment
Form 2877 is filed electronically through the FDA's PREDICT system or in paper form. A defective declaration — or shipment of a non-compliant product without the proper declaration — results in detention at port and possible refusal of admission under 21 U.S.C. § 381.
The form is part of a broader FDA import compliance program that also requires the responsible party to file an annual report (FDA Form 3632) summarizing units imported and any radiation incidents.