ILDA lobbies CDRH on laser light show rules

Sometimes a laser is just a laser. Other times, the smallest change can turn an ordinary laser into something entirely different-something that quickly brings it to the attention of federal safety regulators.

Feb 15th, 2006

PORTLAND, OR - Sometimes a laser is just a laser. Other times, the smallest change can turn an ordinary laser into something entirely different-something that quickly brings it to the attention of federal safety regulators. A 10-mW laser pointer, for example must incorporate certain safety bells and whistles. But add a small spinning mirror on the pointer to create a modest laser light show entertainment effect and the pointer enters a whole new level of federal regulation.

Because the product is to be used for entertainment or informational display purposes, the manufacturer cannot offer the product for sale until the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) reviews and approves a “variance” that allows for the sale of an otherwise prohibited product. Customers cannot buy the product until they apply for and receive a similar variance. And the end user (who also needs a variance) cannot use the product in public until a report is submitted to the CDRH that details where, when and how the product will be used.

The safety rules covering laser display products date back almost 30 years, and have remained virtually unchanged. The rules have undoubtedly acted as a brake on the laser display industry in the United States, making it more difficult to bring products to market and even more difficult to get them into the hands of customers.

The International Laser Display Association, which represents manufactures of users of laser displays, is urging the CDRH to streamline the regulatory process and, at the same time, provide a higher level of safety to the public. At recent public “stakeholders” meeting sponsored by CDRH, it was clear that agency officials were aware of the need for change. Unfortunately, CDRH regulates a huge gamut of devices in a climate of declining resources and increasing workloads.

Back in the disco-crazed era of the 1970s (which gave birth to today’s regulations), lasers light shows were expensive propositions that involved a heavy investment in equipment and expertise. But today you can purchase laser projectors on Ebay, plug them into a standard 120v wall socket, and start entertaining friends, family, and business clients. Of course, you’re also supposed to file that request for a variance and, before you start doing shows, file a “Laser Light Show Report” detailing the when, where, and hows of any “show.”

Unfortunately, some manufacturers outside the United States don’t build their projectors in compliance with CDRH rules and don’t require their U.S. customers to produce proof of a variance as a condition of the sale. And while any variance can be revoked for noncompliance, it rarely happens. Limited resources restrict safety inspections to a handful each year, and there is no systematic enforcement program to go after scofflaws. The result: legitimate companies pay a price for safety compliance, while others skirt the law and reap the profits.

There were rays of hope at the recent stakeholders meeting sponsored by the CDRH, however. The CDRH agrees that it shouldn’t take months to get a variance and agency has embraced the Internet as a tool for submitting variances and for reducing the time it companies must wait to get approval. What I’d like to see is an approach that substitutes real training for time-consuming paperwork. Instead of cutting-and-pasting text into the CDRH variance request, I’d like to see on-line training and testing. If potential purchasers can pass a Web-based test showing they know how to use the equipment safely, they should be able to walk out the door with a laser projector under their arm. ILDA hopes to develop just such as test and, with the help of the CDRH, make it a real tool to promote laser safety.

- David Lytle, Executive Director, International Laser Display Association

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