CDRH Launches Rules Review

June 10, 2005: United States safety officials have announced a broad review of the federal government's radiological safety program with the goal of shifting resources to products and procedures that pose the highest risk to the public.

The review by the Food and Drug Administration’s (FDA) Center for Radiological Health (CDRH) has many laserists hoping for relaxed federal oversight of laser shows and products used to create them. CDRH, however, makes no mention of laser shows in its lengthy initial announcement on the subject. ILDA officials have been in contact with CDRH regarding the review, but at press time no additional details were available.

One of the top goals of the new initiative is to “review and revise product reporting requirements to reduce unnecessary burdens on manufacturers.” ILDA’s Safety Committee Chair, Greg Makhov, is now soliciting information from ILDA members regarding their thoughts on how this goal could be met for the laser show industry (to send email to Greg Makhov, click here).

Manufacturers of laser show projectors in the US must now file a detailed report covering the safety features and radiation emissions of their products. Potential customers must also submit a report to the CDRH regarding their planned use of high-powered laser show products and obtain a CDRH "variance” before they can purchase a projector. Producers of laser shows (or “manufacturers” of shows, in CDRH terminology) must also obtain a CDRH variance and complete a show report in advance of performing a show.

Laser light shows are a relatively small aspect of CDRH’s responsibilities, as the agency regulates a wide range or radiation emitting devices such as medical instruments, televisions, microwave ovens, tanning booths and x-ray systems.

More information about the CDRH’s initiative is posted on-line at: www.fda.gov/cdrh/radhlth/initiative.html