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FDA issues warning for marketing unapproved uses

Device Regulation Alert: Safety, Compliance and Reimbursement News, September 24, 2007

The FDA recently issued a warning to a company claiming that it marketed a device for a use for which the FDA had not given marketing clearance.

In an August warning letter, the FDA alleged Spineology, Inc., was marketing a device for use in procedures requiring structural support when the company's pre-market 510k submission didn't obtain clearance to market that use. The FDA also noted the company had been required to include a contraindication with the device stating it was not for use in cases involving instability and would not provide structural support.

The FDA said it found improper marketing materials on the company's Web site and in a DVD the company distributed at a conference last year. The FDA required the company to:

• review its promotional materials for the product to ensure they comply with the law
• take prompt action to correct the improper marketing
• cease using the promotional materials that include a use not properly cleared
• respond to the warning letter within 15 business days of receipt identifying all the promotional materials similar to the ones discovered by the FDA and stating how the company would cease use of those materials.

The FDA said failure to comply with these requirements could lead it to take regulatory action without further notice including seizure, injunction, or civil monetary penalties. The company has complied with the warning letter and is in discussion with the FDA to include stable vertebral compression fractures as part of its cleared indication, said John Booth, chief executive officer of Spineology.

Click here to read the warning letter.

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