FDA radiation product reporting support
Get a product-specific review of FDA radiation reporting, applicable safety standards and import documents. We help prepare an appropriate filing and track FDA receipt. Ask for a quote based on your product and models.
What we handle
- ✓ Product and intended-use assessment under 21 CFR 1002.1 Table 1
- ✓ Preparation support for applicable product or abbreviated reports
- ✓ FDA receipt and accession-number follow-up for a submitted report
- ✓ Review of applicable annual, supplemental and import documents
Which radiation requirements apply to your product?
The intended use and FDA product code determine the applicable rules. Lasers, X-ray systems, microwave ovens, UV or LED devices, ultrasound and MRI do not all have the same report or annual-report duty. A medical device may have a separate classification, registration, listing or premarket pathway.
Laser products
Laser pointers, laser cutters, laser therapy devices, barcode scanners
The laser hazard class and product design determine the Table 1 report and annual-report entries; medical laser use also needs a separate device review.
X-ray systems
Medical X-ray, dental X-ray, cabinet X-ray for security and industrial use
Medical diagnostic X-ray components and assemblers have record or assembly-report requirements. Baggage-screening X-ray systems have product and annual reports. Requirements differ by intended use and code.
Microwave and RF devices
Microwave ovens, RF welding equipment, diathermy devices
Microwave ovens have product and annual-report entries, with a first-report exception for later models in a category. RF heating or diathermy products have different Table 1 entries.
Ultrasound products
Diagnostic ultrasound, ultrasonic cleaners, ultrasonic welding
Diagnostic ultrasound and scientific-use ultrasound require different product-code and medical-device assessments. FDA's current RAP record lists no radiation safety or annual report.
UV radiation devices
UV curing lamps, UV sterilizers, tanning equipment
UV and LED products are not automatically required to file a product report. The intended use and FDA code control. A medical treatment claim may require a separate medical-device review.
Sunlamp products
Phototherapy lamps, light therapy devices for skin treatment
Sunlamp products and lamps have distinct Table 1 entries. A treatment claim or other medical use calls for a separate device assessment.
FDA LNI
FDA's LNI record for nuclear magnetic resonance spectroscopic systems lists no radiation safety or annual report. General radiation provisions and medical-device rules may still apply.
Does radiation reporting replace medical-device clearance? No. Device classification, establishment registration and listing, and any required 510(k), De Novo or PMA route are separate questions. FDA receipt of a radiation report does not clear or approve a medical device.
A product-specific reporting review
We assess the product first, then confirm the relevant report, records, import declaration and any separate medical-device pathway.
Identify the product and intended use
We review the product code, laser hazard class where relevant, performance standard and Table 1 reporting category. A medical-device pathway is assessed separately; a laser hazard class is not a device class.
Prepare a report where required
If Table 1 requires a product report or abbreviated report, the manufacturer submits it to FDA before placing the product in US commerce. FDA then issues a report accession number as a receipt identifier. An accession number is not FDA approval or import clearance.
Check import and ongoing duties
Form FDA 2877 is an import declaration for products covered by a federal radiation performance standard; it is not the product report. Annual, supplemental and recordkeeping requirements vary by product. Manufacturers remain subject to 21 CFR 1002.20 for accidental radiation occurrences, even when Table 1 requires no product report. We quote only agreed service work.
Questions about radiation product reporting
Is Form FDA 2877 the product report?+
No. It is an import declaration when a covered radiation product is imported. A required product or abbreviated report goes to FDA separately; its accession number identifies FDA's receipt, not approval.
Does every radiation product need an annual report?+
Check 21 CFR 1002.1 Table 1 and the FDA record for the exact product code. Current FDA records for nuclear magnetic resonance spectroscopic systems (LNI) and scientific-use ultrasound (RAP) each show no radiation safety report and no annual report. Other MRI or ultrasound products can differ; general radiation requirements and separate medical-device rules may still apply.
Is the US agent the same as a food facility US Agent?+
Under 21 CFR 1005.25, a foreign electronic-product manufacturer appoints a US resident to receive official legal process, notices and orders before offering the product for import. This is a separate appointment from the US Agent used for food facility registration.
Does radiation reporting replace medical-device clearance?+
No. Device classification, establishment registration and listing, and any required 510(k), De Novo or PMA route are separate questions. FDA receipt of a radiation report does not clear or approve a medical device.
Discuss your radiation product with us
Tell us its intended use, product code if known, model and US import plans. We will assess the relevant reporting and provide a scoped quote. We do not promise FDA approval or customs release.
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