FDA WARNING_LETTER - Futrex Incorporated - November 05, 2012

On February 5, 2013, the FDA issued a Warning Letter to Futrex, Inc. following an inspection from October 22-26 and November 5, 2012. The inspection revealed that Futrex, Inc. manufactures the HealthGuard-15 (HG-15) Blood Pressure and Body Fat Measurement System, which is classified as a medical device.

The HG-15 device was found to be adulterated under section 501(f)(1)(B) of the Act because Futrex, Inc. does not have an approved Premarket Approval (PMA) application or an approved Investigational Device Exemption (IDE). The device is also misbranded under section 502(o) for failure to submit a 510(k) premarket notification, despite Futrex's rationale that it was not required.

Furthermore, the devices are misbranded under section 502(t)(2) due to the firm's failure to adequately develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. Specific deficiencies in Procedure No. 1-068 Rev. C include: 1. Failure to establish internal systems for timely and effective identification, communication, and evaluation of events subject to MDR requirements, lacking definitions for reportable events. 2. Failure to establish internal