There is no official "FDA certification" for laser exports to the United States. The FDA implements a mandatory registration and testing compliance
system for laser products, which is supervised by the Center for Devices and Radiological Health (CDRH) under the US Food and Drug Administration
(FDA). Here are the core points for you to summarize:
1、 Core regulatory basis
The fundamental regulations for exporting laser products to the United States are 21 CFR 1040.10 (Performance Standards for Laser Products) and 21
CFR 1040.11 (Requirements for Specific Purpose Laser Products). All laser products sold or imported in the United States must comply with the aforementioned
federal laser product performance standards.
2、 The FDA does not issue "certificates", the core credential is the Accession Number
The FDA officially does not issue any physical "certification certificates". The so-called "FDA certificate" issued by third-party institutions in the market is
only for commercial display and does not have legal effect. Customs and FDA inspect your Access Number and technical documents.
3、 Complete compliance process (four steps)
Step 1: Product testing and laser grading
The product needs to be sent to a qualified third-party laboratory for full project testing in accordance with 21 CFR 1040.10. The core indicators include
output power, wavelength, beam divergence angle, radiation level, etc., to determine the laser grade (Class I to Class IV). Produce a qualified 'Laser
Radiation Safety Test Report'.
Step 2: Designate a Foreign Representative in the United States
Non US domestic manufacturers must designate an agent within the United States responsible for receiving FDA notifications, assisting in communication,
and contacting emergency situations.
Step 3: Prepare technical documentation
English manuals, circuit diagrams/optical diagrams, component lists (BOM), label samples, production process diagrams, and quality control documents
need to be prepared.
Step 4: Submit registration and product report
Complete enterprise registration (obtain FEI code) and product listing through the FDA's FURLS system, and submit product reports. After FDA approval,
a unique Attachment Number will be issued.
4、 Laser product grading system
The FDA classifies laser products into four levels, with risks ranging from low to high:
Class I: Low risk (such as internal laser in laser printers)
Class II/IIIa: Commonly used in laser pens and barcode scanners
Class IIIb/IV: High risk, such as industrial cutting machines, medical beauty lasers
Different classifications result in vastly different protection requirements and labeling requirements.
5、 Essential for Import Customs Declaration: FDA Form 2877
All laser products entering the United States from abroad must be accompanied by FDA Form 2877 (Declaration Form for Radiation Control Standards
of Imported Electronic Products) when imported, and three copies must be placed on the outer packaging of the goods.
If the product has obtained an Access Number: select Declaration B (meets performance standards) and fill in the archive number
If the product is not certified: it needs to be declared according to Declaration C2 (Temporary Import Guarantee), and the product cannot be used with
electricity. After the exhibition, it must be re exported or destroyed
6、 Label requirements (easily stepped on)
The FDA has strict regulations on laser product labeling, including:
Warning language ("CAUTION" or "DANGER")
Specific symbols and layouts
Non removable aperture label
Directly using the European CE label may result in customs seizure of goods.
Contact phone number: 19925421523
