Case Study: A Fracture Warning

In 2002, a device company that makes a “bone-void filler” received 510(k) clearance to market its product for use in filling bony “voids or defects” except those related to “vertebral compression fractures,” as the label on the product indicated. During a routine inspection of the company, FDA discovered training materials such as presentations, CDs, and informational literature for surgeons that focused on using the device to treat vertebral compression fractures.

February 17, 2010

1 Min Read
Case Study: A Fracture Warning

FDA determined that the company was promoting the device with the training materials, and the promoted use was unapproved. FDA issued the company a Warning Letter for off-label promotion.

Return to "How To Avoid Off-Label Device Promotion."

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