Frequently Asked Questions Regarding the Laser Notice 53 - Guidance for Industry and FDA Staff - Approval of Alternate Means of Labeling for Laser Products (issued March 23, 2007)
Why did the CDRH post Laser Notice 53?
The CDRH wants to reduce unnecessary burdens on manufacturers of laser products. This Notice is a by-product of the CDRH’s new Radiological Health Program - Adapting to Current Public Health Needs - 2005 – 2010
What are some considerations and examples where alternate means of labeling can apply?
Size - The laser product is too small to apply legible certification, identification warning logotype, or protective housing labels. An alternative would be to place these legible certification statements, identification information and warning logo labels on the outside packing of the product, and/or on the front page of the user instructions or directions for use that are included with the product.
Configuration – The shape of the laser product does not lend itself to the application of the required labels.
Design – The laser product is designed as an aiming device inside a barrel of a weapon. The tight tolerance inside the barrel does not allow for use of a label. An alternative would be to have the required labeling and warning logo engraved onto the surface.
Function – The product is likely to be used in an environment where the required labels would be subject to abrasion or chemical degradation
Sterilization - The harsh sterilization will destroy surface labels. An alternative would be to have the required labeling and warning logo engraved onto the surface.
Clearer wording of warning statements – The wordings specified in the standard may be confusing for the design and intended use of the product. The manufacturer wishes to use a more explicit and equivalently safe wording.
My company makes Class IIIb laser products. Can I apply this guidance to these products?
Yes. The Laser Notice 53 is intended for any laser products for which the labeling specified in the standard are not workable or appropriate.
How does this Notice apply to CDs, DVDs, CD-ROMs and other optical disc products? These products come in different sizes, configuration, uses, etc., where some of these labels are impractical or even too small to read?
For products that are considered safe and where there is minimal risk of injury, under normal conditions of use, your company can use alternative means of labeling such as placing certification, identification and warning labeling in various places such as outside packing of the final or finished product itself, user manuals, product’s directions for use. If the low risk laser products are sold to a purchaser or distributor in large bulk, the outside of the container can be labeled. If the low risk laser product is sold as individual package for distribution, the outside of the package or container can be labeled.
The notice says that I should document alternate means of labeling in my product report. Does this requirement mean that I have to submit a supplement or letter to CDRH?
Yes. You should include the actual labels, their wordings, and their locations are in your product report or a supplement to it. However, you do not have to wait for approval from the CDRH for you to use of an alternate means or wording of labeling.
I represent a client who insists that he receives a documented approval of labeling from CDRH. Is a letter or supplement notifying CDRH of alternate means of labeling for my laser products acceptable? Will the CDRH act on my request?
You will receive an acknowledgement letter for the filing, but the CDRH may not act on it or review it because of Laser Notice 53. We do try to cooperate with the manufacturers to the extent that our resources allow.
If CDRH contacts me and advises that my alternate means of labeling does not meet the intent of the regulations and this Laser Notice 53, will I have to recall the products?
Possibly, but not necessarily. The CDRH will exercise its enforcement discretion based on known “risk of injury” to the public and how the product will be used. In most cases where there is no known risk of injury, under normal use, the CDRH will request that you provide the required labels on “future” production or shipment into United States commerce.