FDA Registration for Radiation-Emitting Products
Product reports, annual reports, and accession number filing for lasers, X-ray systems, microwave devices, ultrasound equipment, and other radiation-emitting electronics exported to the United States. Pricing depends on your product type and number of models.
What we handle
- ✓ Manufacturer accession number registration
- ✓ Initial product report (Form FDA 2877)
- ✓ Annual report preparation and filing
- ✓ Supplemental reports for product changes
- ✓ Performance standard compliance review
Which Products Require FDA Registration?
Under 21 CFR Part 1002, all manufacturers and importers of electronic radiation-emitting products must register with FDA's Center for Devices and Radiological Health (CDRH) before the product enters US commerce.
Laser products
Laser pointers, laser cutters, laser therapy devices, barcode scanners
X-ray systems
Medical X-ray, dental X-ray, cabinet X-ray for security and industrial use
Microwave and RF devices
Microwave ovens, RF welding equipment, diathermy devices
Ultrasound products
Diagnostic ultrasound, ultrasonic cleaners, ultrasonic welding
UV radiation devices
UV curing lamps, UV sterilizers, tanning equipment
Sunlamp products
Phototherapy lamps, light therapy devices for skin treatment
How FDA Radiation Product Registration Works
Five stages from product classification to ongoing annual compliance.
Product Classification Review
We confirm whether your product falls under 21 CFR 1002 and identify the applicable performance standards (21 CFR 1010, 1020, 1030, etc.). Products already exempt or subject to FDA medical device rules receive a separate assessment.
Accession Number Application
Before filing any report, a manufacturer accession number must be obtained from FDA's Center for Devices and Radiological Health (CDRH). We handle this registration on your behalf.
Initial Product Report (Form FDA 2877)
A product report must be filed before the product is introduced to the US market. We prepare and submit Form FDA 2877 with all required technical data: product model, radiation type, output levels, and safety features.
Annual Report Preparation
Manufacturers must file an annual report for each reported product model that continues to be manufactured. We prepare the annual update covering production volume, model changes, and any non-compliances identified.
Supplemental Reports for Changes
Design changes that affect radiation output or safety features must be reported to FDA via a supplemental report before the modified product ships. We monitor your product updates and file reports as changes occur.
Common questions about radiation product registration
What is 21 CFR 1002?+
21 CFR Part 1002 sets the reporting and recordkeeping requirements for manufacturers and importers of electronic products that emit radiation. Any manufacturer introducing such a product into US commerce must register with FDA, file initial product reports, and submit annual reports.
Which products require FDA radiation registration?+
Products covered include lasers, X-ray systems, microwave ovens, ultrasound devices, UV lamps, sunlamps, and any other electronic product that emits ionizing or non-ionizing radiation. FDA's CDRH program covers consumer, medical, and industrial products.
Is this the same as FDA medical device registration?+
No. Radiation-emitting product reports under 21 CFR 1002 are separate from the 510(k) or PMA medical device clearance process. Some products — such as medical X-ray systems or laser surgical devices — may require both. We identify exactly which filings apply to your product.
What is Form FDA 2877?+
Form FDA 2877 is the standard product report form for radiation-emitting electronic products. It collects product identification, radiation characteristics, safety features, performance standard compliance, and manufacturer information. It must be submitted before a product is introduced into commerce.
When must annual reports be filed?+
Annual reports are due once per year for each product model still in production. They cover the number of units manufactured, any product changes, and any defects or failures identified during the year. FDABridge tracks your reporting schedule and prepares each annual submission.
What happens if a product is sold without registration?+
Selling a radiation-emitting product in the US without a valid CDRH registration is a Federal violation. FDA can issue Warning Letters, detain imports at the border, require recall, or pursue civil penalties. The registration itself is straightforward — there is no reason to delay.
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