1、 Regulatory positioning
21 CFR 1040.10 is a mandatory federal regulation for laser product performance standards issued by the CDRH (Center for Devices and Radiological Health) under the US FDA. Laser engraving machines, as radiation emitting electronic products, must pass this standard testing and submit product reports to the FDA before being exported or sold in the United States.
2、 Laser level classification
The FDA classifies laser products into five categories based on their level of harm: Class I (no harm), Class II (low-power visible light), Class IIIa (medium power), Class IIIb (high power), and Class IV (high power). Laser engraving machines typically involve Class IIIb or Class IV, corresponding to the strictest testing and labeling requirements.
3、 Core testing items
Laser output power test
Measure the output power, maximum output, and stability of continuous wave (CW) lasers; For pulsed lasers, test the single pulse energy, pulse width, repetition rate, and peak power. The test results are used to determine the laser level to which the product belongs.
Laser wavelength testing
Measure the center wavelength, wavelength range, and multi wavelength output to confirm consistency with product specifications.
Divergence angle and beam quality testing
Measure the beam spread angle, spot size, and irradiation area for assessing the risk of human eye exposure and grading.
Test of achievable emission limit (AEL) and maximum permissible exposure (MPE)
According to 21 CFR 1040.10 (d), verify whether the achievable emission level of laser products is within the safety limit of the corresponding level, and evaluate the human eye safety level.
Assessment of protective structures and interlocking devices
Check if the casing can effectively prevent human exposure to hazardous laser radiation; Verify whether the safety interlock device can reliably cut off the laser output when the protective cover is opened or in maintenance mode; Evaluate the functions of key switches, remote interlock connectors, etc.
Label and Identification Review
Verify whether the product is affixed with FDA compliant certification/identification nameplates, laser grade labels, warning labels (such as "AVOID Directive EYE EXPOSURE"), and aperture labels. Class IIIb and IV products must have warning symbols and specific warning statements.
4、 Technical document requirements
Before testing, it is necessary to prepare: product manual, assembly diagram, circuit diagram, optical path diagram, structural diagram, product nameplate photo, laser generator parameters, laser protection measures and working principle explanation, quality control process documents, etc.
5、 Content of the testing report
The complete testing report should include: cover page (product name, model, manufacturer, testing date), product description (structure, laser source, purpose), laser grade determination (grade, wavelength, maximum output), list of testing equipment (model and calibration status), data from each test result, label photos, and compliance conclusions.
6、 FDA registration and report submission
After the testing is completed, the manufacturer needs to submit a Laser Product Report through the FDA electronic submission system to obtain a unique Attachment Number. This number only indicates that the FDA has received the report, not the product's "approval" certificate. Overseas manufacturers must designate agents within the United States.
7、 Annual reporting obligation
After obtaining the Accession Number, the manufacturer must submit an annual report to the FDA before September 1st each year, covering production, sales, and design changes related to the United States from July 1st of the previous year to June 30th of the current year. Failure to submit on time may affect the product's admission status.
8、 Design Change Management
If there are significant design changes after the product is launched (such as changing the laser type, adjusting the output power, modifying the safety interlock structure, etc.), a supplementary report must be resubmitted to the FDA to ensure that the actual shipped product is completely consistent with the recorded technical information.
9、 Relationship with IEC 60825-1
FDA Laser Notice No. 56 allows manufacturers to use the classification and labeling system of IEC 60825-1:2014 instead of the native 21 CFR requirements, but must indicate a declaration of conformity on the label. This can simplify the compliance path for products exported to both the European Union and the United States, but FDA registration and report submission remain independent legal requirements for the US market and cannot be replaced solely by IEC reports
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