USA FDA Registration Process for Laser Products

Laser technology is widely applied in modern society, especially in fields like medicine, communication, and material processing. To ensure the safety of laser products, any laser product exported to the United States must undergo FDA certification.

Laser Products Involved:

- Barcode scanners

- Presentation projectors

- Aiming lasers

- Rangefinders

- Laser printers

FDA Standards and Labeling Requirements:

The CDRH of the FDA requires laser products marketed in the United States to comply with the technical and labeling requirements specified in CFR 21 Part 1040.10 and Part 1040.11.

CDRH recognizes the following IEC (International Electrotechnical Commission) standards:

- IEC 60825-1 – Safety of Laser Products

- iec 60601-2-22 – Medical Electrical Equipment

Labeling Requirements

According to CFR 21 Part 1010.2, importers and manufacturers of laser products should label their products. The labels must declare that the product complies with applicable U.S. standards and legal requirements. All information should be written clearly and legibly in English. Examples of such labels, considered as certificates for the product, include:

- "Complies with 21 CFR Chapter 1, Subchapter J."

- "Complies with 21 CFR Part 1040.10 and 1040.11."

CFR 21 Part 1040.10 also explains general labeling requirements for laser products, depending on the hazard classification. The product must display:

- Warning symbols

- Specific warning statements

- Maximum output

- Pulse duration (if pulsed)

- Laser medium or emitted wavelength

- Identification label

Identification labels must include:

- Manufacturer’s name and address

- Place of manufacture

- Month and year of manufacture (written in full)

Required Documentation for Laser Product and Instrument Manufacturers:

1. Guide for Preparing Product Reports on Lasers and Products Containing Lasers

2. Guide for Preparing Annual Reports on Radiation Safety of Laser Light Shows

3. FDA eSubmitter

FDA Registration Process for Laser Products:

Application Form

Fill out the application form: Include company information, product information, etc.

Product Documentation/Technical Information

Prepare detailed manuals, sales brochures, installation guides, maintenance manuals, assembly drawings, and technical information about the product. Describe any laser protection measures and their working principles.

Labeling

Ensure compliance with regulations for English labels, including warning labels, product labels, conformity certification labels (e.g., Complies with 21 CFR 1040.10 & 1040.11), and beam aperture labels.

Laser Device Information

Provide information about the laser generator type, medium, laser path diagram, laser parameters, and certification/testing records of the laser device. If purchased from another manufacturer, include the manufacturer’s information, laser device parameters/datasheet or manual, and FDA certification/number if applicable.

Calibration Certificate and Report

Submit the annual calibration certificate and report of the power meter.

Quality Control Documentation

Include internal quality control flowcharts, inspection procedures, quality control specifications (e.g., design modification controls), production line sampling forms, incoming material inspection forms, finished product inspection forms, and internal inspection reports (with sample forms).

U.S. Agent and Importer Information

Provide information about the U.S. agent and importer, including full contact name, phone/fax/email, detailed U.S. address/ZIP code, and company name.