Laser Safety Laser Light Show at PSU
Laser Light Shows require a variance from the FDA CDRH. The issuance of the variance for laser light shows is based upon the FDA’s determination that the product performs a function or is intended for a purpose which could not be performed or accomplished if required to meet the applicable standards, and suitable means for assuring radiation safety or protection are provided.
You need to obtain the variance documentation from the light show provider. If the variance has not yet been approved, the letter of request for a variance may be acceptable. Provide EHS with the following information:
- A copy of the last variance issued by the Center for Devices and Radiological Health (CDRH)
- A copy of the most recent annual report letter from the vendor to the CDRH
- A copy of the report filed with the CDRH for the show to be performed at the University
- A copy of the MSDS for any fog or haze fluid that may be used as part of the show
- Name and contact information for the laser show vendor
Risk management will of course be the group that approves the contract with the laser tag or laser light show vendor, contact them at 814-863-5538. They will only approve the contract after EHS has indicated that the vendor has submitted the required documentation.