Salt Lake City, Utah - On

City, Utah - On July 15, 2005, Utah Medical Products, Inc. (Nasdaq:UTMD) filed

an administrative claim with the Department of Health and Human Services (HHS),

the parent of the U.S. Food & Drug Administration (FDA), under the Federal

Tort Claims Act (FTCA), alleging abuse of process in relation to the negligence

and wrongful acts of FDA employees while acting within the scope of their

employment during the inspections, review and subsequent enforcement actions

taken and/or attempted, including public statements, during the period of 2001

February 14, 2006, UTMD received a letter from HHS dated February 10,

letter constitutes the notice of final determination on this claim, as required

by 28 U.S.C. '1346(b). Your client's [UTMD's] claim is not cognizable under the

FTCA. Accordingly, the claim of Utah Medical Products, Inc, is hereby

February 15, 2006, as part of informing public shareholders of the HHS denial,

UTMD indicated that it had an August 9, 2006 deadline to file suit against

FDA in the federal district court, or file a request for reconsideration. In

order to disseminate an answer to shareholder follow-up questions fairly, the

Company is announcing that it filed a request for reconsideration with HHS

July 12, 2006. The request for reconsideration is now available to the public

UTMD's website www.utahmed.com,

contacting Kevin Cornwell.

remains UTMD's conviction that the claim is valid. The request for

reconsideration includes the following:

Medical believes that the Company, its employees, shareholders, suppliers and

customers, along with all other taxpaying and non-taxpaying U.S. citizens,

entitled to expect that the federal government will act in good faith to carry

out its responsibilities, and not waste dear taxpayer resources for an improper

purpose. Utah Medical respectfully seeks the following administrative remedies:

removal of the August 10, 2004 FDA press release which remains posted on the

(acknowledging the irreparable harm that has been done to UTMD's reputation for

manufacturing high quality products) posting of a public press release from

FDA (in manner and form similar to the August 10, 2004 press release posted

the FDA's website) acknowledging that Utah Medical's quality system is

has been in compliance

QSR (per the U.S. Court's judgment);

public declaratory statement from the Secretary of HHS that FDA must comply

its own regulations, and that unethical conduct that violates the Standards

Ethical Conduct for Employees of the Executive Branch (5 CFR Part 2635) will

the FDA inspectors and reviewers complicit in the 2001- 2003 Utah Medical

inspections, and ensuing improper treatment of Utah Medical, be barred from

future involvement with Utah Medical;

purging of the FDA's administrative file of all FDA-483s, EIRs, CDRH memos,

interoffice e-mail, other fraudulent memoranda related to the 2001 through

inspections and recommendations for permanent injunction (or at least a cover

letter to all documents subject to the FOIA that states, "Despite the contents

of these documents, Utah Medical was found to be in full compliance with the

by an independent Court. Therefore, the veracity of any of these documents

cannot be relied on or verified.");

commitment from HHS, or some suitable government entity independent of the

to conduct and document the results of a formal investigation of FDA actions

this case, to publicly disclose the results and to retrain, reprimand, reassign

and/or dishonorably discharge FDA personnel who violated government rules and

provide recovery of pecuniary damages incurred by Utah Medical as the result

the conduct of the FDA.

criticism, Rep. Henry A. Waxman, D-Calif., stated that "the FDA can't do its job

when its enforcement arm is tied behind its back." In response, David Elder,

Director of the FDA Office of Enforcement, was quoted in the August 2006 issue

of the "Guide to Medical Device Regulation," as follows:

enforcement cannot be properly judged by counting the number of actions taken

the agency," he [Elder] said. "FDA has increasingly used an enforcement strategy

based on efficient risk management principles that focuses on combating the

greatest public health risks and maximizing our deterrent effect against

potential violators. As

a result of FDA's focus on those firms and those violations that present the

highest risk to consumers and public health, the agency has taken prompt,

targeted and aggressive action against firms that are in violation of

to UTMD CEO Kevin Cornwell,

with Mr. Elder that the number of administrative Warning Letters issued by

has no correlation with the quality of medical devices being manufactured by

industry. I also agree that FDA should be allocating its limited enforcement

resources based on risk to the public health. But that's where my agreement with

question the basis for Mr. Elder's statements, because his representation about

FDA using efficient risk management principles does not comport with UTMD's

experience with the FDA. To my knowledge, the lawsuit brought by FDA in 2004

seeking an injunction to shut down UTMD's operations because of alleged

violations of the Quality System Regulation (QSR) has been the only

litigated through trial on behalf of the FDA in the ten years since promulgation

of the QSR. After three years of intensive and extensive inspections of UTMD

"review" by so-called agency experts, the federal court decided unequivocally

against the FDA. Utah Medical was

compliance with the QSR!

contrast to Mr. Elder's statement, the FDA's action was neither prompt nor based

the public. The fact that no risk assessment was ever done by the FDA was a

travesty. There were no FDA allegations that UTMD's devices were defective, or

not safe or not effective. The agency never investigated whether UTMD's finished

devices met specifications, and never challenged the soundness of the risk

assessments that we had performed."

published mission statement states, in part,

is responsible for protecting the public health by assuring the safety,

efficacy, and security of human and veterinary drugs, biological products,

medical devices, our nation's food supply, cosmetics, and products that emit

Cornwell further states,

has the power to destroy public institutions and people's careers and lives.

That power should be used carefully and judiciously. If there's not a risk to

public health, FDA should not be capriciously using its power to punish people.

It's a direct contradiction to their mission.

needs to use the principles of quality assurance to learn from this UTMD

experience, and respond responsibly to our request for remedies. I do not

understand how the leadership of the FDA can reconcile the fact that it is

significant violation of the Quality System Regulation (QSR) when companies

not follow their written procedures, but when employees of the FDA, which is

charged with the enforcement of the QSR, do not follow important agency