Sellers of Laser Products Must Have A FDA Accession Number
Online vendors such as Amazon require documentation of a U.S. Food and Drug Administration (FDA) accession number for certain laser products sold through their online platforms. An accession number is a unique identifier that FDA uses to track reports from specific models of radiation-emitting electronic devices (RED). FDA requires manufacturers of certain RED products to have an accession number for their product prior to marketing it in the United States.
How Do I Get an Accession Number for my Laser Product?
In order to obtain an accession number, FDA requires manufacturers of most laser products to submit a product report consisting of numerous aspects including:
- Identifying information for the product and manufacturer
- Information on components and accessories, as well as functions and uses that may affect the product’s radiation emissions
- Measures taken to control levels of radiation in the product
- Warning statements and instructions for use related to the product’s radiation safety
After a manufacturer submits a report, FDA issues an acknowledgement letter containing the product’s accession number. The letter does not constitute FDA approval of the device.
When a business has an accession number for a laser product, FDA further requires annual reporting for the product to be submitted by September 1st of each year. Among other aspects, annual reports must contain a description of quality control procedures for the device, as well as test results and copies of communications relating to radiation safety of the device.
FDA reporting requirements apply to most laser products a business may want to sell through online vendors. Even products as seemingly harmless as spinning tops with laser lights and laser cat toys are subject to reporting. Failure to report may not only prohibit the sale of your product through Amazon and similar platforms, but may also result in detention of your shipments at the U.S. border.
For companies considering selling laser products through Amazon, Registrar Corp’s Regulatory Specialists can help determine the specific requirements for your product and facilitate reports with FDA. If you are located outside of the United States, Registrar Corp can also serve as your U.S. Agent for Service of Process. Simply complete the form below or call us at +1-757-224-0177. Alternatively, you can chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.