Salt Lake City, Utah - Utah Medical Products, Inc. (Nasdaq: UTMD) announces that two FDA investigators have concluded a full QSIT inspection used to assess a medical device manufacturer's compliance with the Quality Syst

City, Utah - Utah Medical Products, Inc. (Nasdaq: UTMD) announces that two FDA

investigators have concluded a full QSIT inspection used to assess a medical

device manufacturer's compliance with the Quality System Regulation (QSR) and

related regulations. The inspectional process, known as the "Quality System

Inspection Technique" or QSIT, guides field investigators in conducting an

efficient and effective comprehensive inspection, focusing on key elements of a

firm's quality system.

investigators use a Form FDA 483 to notify management in writing of significant

objectionable observations which, in the investigator's judgment, indicate a

medical device is adulterated or prepared under conditions where the device may

become adulterated. At the conclusion of the UTMD inspection last

Friday, the FDA investigators determined that there was no need to issue a Form

FDA 483. In the industry, this is known as a "clean" inspection and

evidence that FDA investigators have concluded that the Company is in compliance

with FDA requirements for manufacturing medical devices. UTMD appreciates the

professionalism and objectivity of the recent investigators.

believes that this is significant since this inspection was the first FDA

inspection of the Company since 2004. After the 2004 inspection, the

FDA filed a lawsuit against UTMD alleging that the Company had significant

objectionable conditions. The lawsuit was adjudicated in Federal Court in 2005

with the Court concluding completely in UTMD's favor and finding that UTMD's

quality system was in compliance with the QSR.

to CEO Kevin Cornwell,

anyone - customers, potential customers, clinicians, hospital administrators and

others in the medical device supply chain - who had doubts or concerns that the

FDA had issues with UTMD's quality system, the results of this recent inspection

should lay those to rest. The millions of UTMD devices used in critical care

situations with expected outcomes are clear evidence that UTMD's quality system

overall is working as intended in the QSR, and consistent with UTMD's decades of

commitment to excellence."

Medical Products, Inc., with particular interest in health care for women and

their babies, develops, manufactures, assembles and markets a broad range of

disposable and reusable specialty medical devices.