- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological HealthOffice of Regulatory Affairs
On February 21, 1978, the Bureau of Radiological Health (BRH), now the Center for Devices and Radiological Health (CDRH) established an interim enforcement policy for certain laser light shows and displays. That document established the policy that the Bureau would not object to the assembly and continued operation of any laser light show, display, and/or device in the absence of a variance, if a specified set of conditions including operational safety criteria were satisfied. This policy was published in the Compliance Policy Guide Manual on 12/26/78.* * At that time, processing an application for a variance from one or more requirements of a performance standard involved a lengthy process. On August 17, 1979, an amendment to the administrative procedures for ruling on variance applications was published in the Federal Register and became effective on September 17, 1979. This amendment permits a simplified and expedited variance procedure.
Because of this reduction in the time required to obtain a variance, there is no longer any reason to permit laser light shows, displays, or devices that do not comply with the requirements of the standard for demonstration laser products (i.e., they are Class IIIb or IV laser products) to be introduced into commerce unless a variance (specific authorization to vary from the standard) has been obtained. * *
Effective August 20, 1985, all manufacturers or assemblers of Class IIIb or IV laser light shows, displays, and devices manufactured or assembled after that date must have an approved variance before introduction into commerce or continuing their operation. The Food and Drug Administration will take appropriate enforcement action to prevent the manufacture, assembly, introduction into commerce, and continued operation of Class IIIb or IV laser light shows, displays, and devices which fail to comply with the laser product performance standard and with the conditions of the applicable variance.
*Material between asterisks is new or revised."
Revised: 3/95 , 3/2005
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2013-S-0610.