1、 Regulatory nature: Belongs to "laser products" rather than medical devices
Wind lidar (such as ground-based Doppler wind lidar, cabin type/forward view radar) is not considered a medical device in the US market, and therefore does not go through medical device approval paths such as 510 (k) and PMA. Instead, it is regulated by the FDA's Center for Devices and Radiological Health (CDRH) as a "laser product in radiation emitting electronic products". The legal basis for this is the "Radiation Control of Electronic Products" provision in Chapter V, Subcapter C of the Federal Food, Drug, and Cosmetic Act, specifically located in 21 CFR Parts 1000-1040 (Subcapter J, Radiological Health). The FDA explicitly states that whether laser products are medical devices or not, they are subject to the same set of laser product regulations.
2、 Core compliance path: self certification+product report+Attachment Number
There is no traditional "registration certificate" approval in the United States, but rather a manufacturer self certification model. The key points of the process are as follows:
1. Product classification and testing: First, complete the laser safety level classification according to 21 CFR 1040.10 or IEC 60825-1 (CDRH classification is Class I-IV, corresponding to IEC Class 1-4). Wind measurement radar is commonly classified as Class 1M or Class 4 (high-power pulse type). Testing must be completed in a recognized laboratory and a report must be issued.
2. Submit Product Report: According to 21 CFR 1002.10, submit a report to CDRH before the product enters commercial circulation in the United States, including manufacturer information, product identification information (model, wavelength, maximum output power, etc.), and safety features. After the report is accepted by the FDA, an Access Number will be assigned, which is a key credential for the product to enter the US market legally and needs to be referenced during import customs clearance. Please note that the Attachment Number only represents the report being received and entered into the database, and does not equate to FDA approval.
3. Supplementary Report and Annual Report: Product changes or new models require submission of a Supplementary Report; Manufacturers are also required to submit an annual report on the quantity of products sold in the United States and their radiation safety history. When importing, FDA will verify the manufacturer's Accession Number and annual report status.
3、 Reduce duplicate testing using IEC 60825-1: Laser Notice 56
The FDA's laser safety performance standards differ from IEC 60825-1 in terms of grading system, label format - CDRH requires CAUTION/DER specific format combination labels, non removable aperture labels, etc. Through the Laser Notice No. 56 guidelines, manufacturers can demonstrate compliance based on the classification and labeling of IEC 60825-1 Ed.3 (and IEC 60601-2-22 Ed.3.1). The FDA does not currently enforce certain provisions of 21 CFR 1040.10/1040.11. Laser Notice 50 was abolished on December 31, 2024, and new applications must comply with Notice 56. If a Chinese manufacturer's product already has an IEC 60825-1 report, it is usually declared according to the "21 CFR 1040.10+Laser Notice 56" path.
4、 Labeling and identification requirements
Each product must be affixed with a certification label that complies with 21 CFR 1010.2 (such as "Complies with 21 CFR 1040.10 and 1040.11"), and equipped with warning labels, output parameter labels, and manufacturer identification labels in accordance with the requirements of 1040.10; Products without certification labels will be refused entry.
5、 Import requirements
Foreign manufacturers should pay attention to:
Designated U.S. Agent: Foreign manufacturers are required to designate a U.S. agent in accordance with 21 CFR 1005.25 when preparing product reports.
Form FDA 2877: When importing, the "Radiation Control Standard Product Declaration" form must be accompanied by the Customs and Border Protection (CBP) to fill in manufacturer information, country of origin, product description, model, and Attachment Number.
Waiting time for acceptance: After submitting the report, it usually takes at least one month to receive an acceptance receipt. It is recommended to use FDA eSubmitter electronic submission to speed up the process.
6、 Summary
The essence of FDA registration for wind lidar is to complete 21 CFR 1040.10 self certification as a laser product → submit a product report to CDRH (recommended based on IEC 60825-1+Laser Notice 56) → obtain an Attachment Number → add a compliance label → submit an annual report → fill out FDA Form 2877 when importing. The entire process has no substantive technical review, and the cycle mainly depends on testing and report preparation, which can usually be completed within a few months. The difficulty lies in the differences in the labeling system and the maintenance of ongoing obligations such as annual reports.
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