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Buyer beware: What's your new technology FDA approved for?

Credentialing Resource Center Connection, March 26, 2009

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PathoLase is marketing its PinPointe laser as a treatment for toenail fungus even though the product was approved by the Food and Drug Administration (FDA) in 2001 for use in dentistry, according to a March 20 New York Times article.

“Technically, the FDA does not regulate the practice of medicine, so doctors are indeed able to use approved drugs and devices for unapproved purposes when they deem it appropriate,” the article states.

However, it is illegal for companies to market a product for unapproved indications, Timothy A. Ulatowski, director of compliance at the Center for Devices and Radiological Health at the FDA, told The New York Times.

This case brings to light a question that medical staffs need to ask themselves before introducing a new technology at their organization: “Even though it may not be illegal to do so, are we granting practitioners the privilege to use the technology for the purpose for which the FDA approved it?”

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