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.
