Regulatory Focus™ > News Articles > In Rare Warning Letter, FDA Hits Company for Making Unapproved Claims About Device

In Rare Warning Letter, FDA Hits Company for Making Unapproved Claims About Device

Posted 13 March 2014 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) this week sent a rare Warning Letter to a medical device manufacturer chiding it for promoting its product for a purpose not approved by the agency.

The 26 February 2014 Warning Letter to NeoMedix Corporation references the company's Trabectome High Frequency Generator, a device cleared earlier for use with compatible electrosurgical instruments in low-power microsurgical applications for the removal, destruction and coagulation of tissue under 510(k) application K061258.

At the time of its 510(k) clearance in 2006, FDA said it found that the device was substantially equivalent to the Aaron Medical Model 800 High Frequency Desiccator cleared under K955681.

But according to FDA's Warning Letter, NeoMedix has been promoting the product in various fora for use in glaucoma patients.

"The K061258 submission did not include data regarding the treatment of glaucoma, and the device was not cleared for the treatment of glaucoma," FDA noted.

After a review of the company's website, FDA said it found evidence of a recent invitation to and an agenda for a training session for the device.

Quoting those materials, FDA said the company had promoted Trabectome for the "minimally invasive surgical management of glaucoma," "for minimally invasive treatment of glaucoma," and "33% IOP [intraocular pressure] Reduction on Average." 

The Warning Letter is unusual in several respects. First, relatively few Warning Letters to device companies reference promotional claims. Second, the turnaround of the Warning Letter was unusually quick. FDA's observation on NeoMedix's page was made on 25 February 2014, and the letter was sent to the company on 28 February 2014. By contrast, some manufacturing-based letters can take months from the time of the observation to the time a Warning Letter is sent.

The company was asked to immediately remove the training materials from its website and ordered to cease similar misbranding in the future.

At the time of this article's posting, the Trabectome website still featured extensive information about the product's use for glaucoma.


Warning Letter to NeoMedix

Regulatory Focus newsletters

All the biggest regulatory news and happenings.