2013 Year in Review: CDRH Promotion and Marketing Enforcement Letters

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In 2013, FDA’s Center for Devices and Radiological Health (CDRH) made publicly available on its website a total of 22 promotion and marketing-related enforcement letters to device manufacturers. Of the 22 enforcement letters, 21 were Warning Letters. Although FDA stated publicly that it would begin publishing (for the first time) Untitled Letters on its website, FDA made publicly available only one Untitled Letter in 2013.

The vast majority of the 2013 enforcement letters resulted from CDRH review of company or product websites. However, 5 of the 22 letters cited materials reviewed by FDA during a manufacturing facility inspection. All five of those inspection-based letters were issued to foreign manufacturers in either China, South Korea or India.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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