A comprehensive resource for safe and responsible laser use

US: FDA proposes amending Federal laser manufacturer regulations

The Food and Drug Administration is proposing to amend the Federal Performance Standard for Laser Products (21 CFR 1040.10 and 1040.11). FDA says the changes are intended to 1) put U.S. standards closer to international IEC 60825 standards, 2) to help manufacturers lower costs, 3) to improve FDA’s effectiveness in regulating laser products and 4) to better protect and promote the public health.

The proposal was issued in the Federal Register on June 24 2013. The public may send comments to FDA until September 23 2013. FDA will then evaluate the comments, make any changes as a result, and at a future date will put the amendments into effect.

For consumer lasers, the most significant proposal is to create a new category of specific purpose lasers, “children’s toy laser products.” FDA says these could include lasers intended for creating entertaining optical effects, dancing laser beams projected from a stationary column, spinning tops which project laser beams, or lasers mounted on toy guns for “aiming.” FDA defines such toys as “a product that is manufactured, designed, intended or promoted for use by children under 14 years of age.”

The laser inside such a toy would be restricted to Class I (less than 1 mW for visible light). This is because FDA is concerned that if the toy were broken or disassembled, a higher power laser could harm a child.
FDA further proposes that “if a children's toy laser product also meets the definition of a demonstration laser product or surveying, leveling, and alignment laser product, then the classification limit for children's toy laser product applies.”

The proposed harmonization with IEC standards codifies current FDA practice as set forth in Laser Notice 50, issued in 2001 and updated in 2007. FDA estimates that manufacturers would incur a one time cost totaling about $6 million, but afterwards there would be expected recurring benefits (from not having to meet two different standards) of $13 million.

Comments can be submitted by email or postal mail. As of July 29 2013, there were no comments listed at the Regulations.gov web page for the FDA proposal.

Electronic submissions
Submit electronic comments in the following way: Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

Written submissions
Submit written submissions in the following ways: Mail/Hand delivery/Courier (for paper, disk, or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name, Docket No. FDA-2011-N-0070, and RIN 0910-AF87 for this rulemaking. All comments received may be posted without change to http://www.regulations.gov, including any personal information provided.

Reading the proposal and any comments
Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov and insert the docket number FDA-2011-N-0070 into the “Search” box and follow the prompts, and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

A copy of what 21 CFR 1040.10 and 1040.11 would look like with all the proposed amendments is here. This was prepared by Robert Aldrich as an aid to understanding the FDA proposal. He notes: “I have made a good-faith effort to mimic their draft verbatim. But I could have mistyped or misunderstood something from what I was creating from. Please keep that in mind.”