FDA’s Proposed Change to the Regulation of Laser Pointers

By Patrick Murphy In October 2016, the U.S. Food and Drug Administration (FDA) put forth a preliminary proposal to declare green, blue, yellow and violet laser pointers as “defective.” Only orange-red and red laser pointers would be allowed to be manufactured, imported or sold in the U.S. This proposal was in response to the thousands […]

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Regulatory Science and Laser Safety Research at the FDA

By Daniel X. Hammer, William Calhoun, Do-Hyun Kim, Robert James, Ilko K. Ilev and Victor Krauthamer The Food and Drug Administration’s Center for Devices and Radiological Health (FDA/CDRH) regulates medical devices and radiological products in the US. We approve new devices that are deemed to be safe and effective and clear for sale devices which […]

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