FDA issues warning to wound therapy device maker

04/10/2012 | MedCityNews.com

The FDA sent a warning letter to device maker Ogenix for failing to adequately test design changes to its Epiflo wound healing device, failing to analyze risks involving the device's strength and durability, and failing to follow recordkeeping requirements. The letter was "routine," said Craig Davis, a managing director with Ogenix, and the company has already responded.

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