-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, A87CfjQWWWVrHE+OoUNINwDfYZvkNiwWvbG3lHa8KXUmx29KGlTIRgozvAMq6l2N WgspJo9PPTEo2B/wh89a5Q== 0001096906-05-000729.txt : 20051117 0001096906-05-000729.hdr.sgml : 20051117 20051117121839 ACCESSION NUMBER: 0001096906-05-000729 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20051116 ITEM INFORMATION: Other Events FILED AS OF DATE: 20051117 DATE AS OF CHANGE: 20051117 FILER: COMPANY DATA: COMPANY CONFORMED NAME: UTAH MEDICAL PRODUCTS INC CENTRAL INDEX KEY: 0000706698 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 870342734 STATE OF INCORPORATION: UT FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-12575 FILM NUMBER: 051211857 BUSINESS ADDRESS: STREET 1: 7043 S 300 WEST CITY: MIDVALE STATE: UT ZIP: 84047 BUSINESS PHONE: 8015661200 8-K 1 utahmed8k111605.htm UTAH MEDICAL PRODUCTS FORM 8-K NOVEMBER 11, 2005 Utah Medical Products Form 8-K November 11, 2005



UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934



Date of Report (date of earliest event reported): November 16, 2005


Commission File No. 0-11178


UTAH MEDICAL PRODUCTS, INC.
(Exact name of Registrant as specified in its charter)


UTAH
87-0342734
(State or other jurisdiction of incorporation or organization)
(I.R.S. Employer Identification No.)
   

7043 South 300 West
Midvale, Utah 84047
Address of principal executive offices


Registrant's telephone number:    (801) 566-1200



 

 
ITEM 8.01 OTHER EVENTS


 
On November 17, 2005, Utah Medical Products, Inc. issued a press release announcing that on November 16, 2005 it received confirmation that the FDA is honoring UTMD’s request to issue Certificates to Foreign Governments. A copy of the press release is attached hereto as Exhibit 99.1
 
 


SIGNATURES



Pursuant to the requirements of the Securities Exchanges Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


 
UTAH MEDICAL PRODUCTS, INC.
 
REGISTRANT
     
     
Date:         11/17/05            
By:
  /s/ Kevin L. Cornwell
   
Kevin L. Cornwell
   
CEO






EXHIBIT INDEX



Index
Number
Description
   
99.1
Press release issued November 17, 2005: Utah Medical Products, Inc. Receives CFGs from FDA
 
 
 
 
 
 

EX-99.1 2 utahmed8k111605ex99-1.htm EXHIBIT 99.1 Exhibit 99.1



EXHIBIT 99.1

Salt Lake City, Utah - On November 16, 2005, Utah Medical Products, Inc. (Nasdaq: UTMD) received confirmation that the U.S. Food & Drug Administration (FDA) is finally honoring UTMD’s request to issue Certificate to Foreign Governments (CFGs or “export certificates”) that provide nonbinding assurance to foreign entities that UTMD is manufacturing its products in Utah in accordance with the provisions of the Quality System Regulation (QSR). The certification reads,

“It is certified that the above [all of UTMD’s] products may be marketed in, and legally exported from, the United States of America at this time.  On October 21, 2005, the United States District Court for the District of Utah ruled that the manufacturing plant in which the products are produced is in compliance with current good manufacturing practice requirements for the products listed above.” 

Although UTMD has never been restricted from distributing its medical devices, either within the U.S. or outside the U.S., for the last two and half years the FDA had refused to provide export certificates. UTMD’s inability to timely provide CFGs limited its participation in certain foreign tender offers, and reduced interest by some of its foreign distributors in distributing UTMD’s products.

According to CEO Kevin Cornwell,
“Refusing to issue CFGs was the basis for the lawsuit that UTMD filed in June 2003 against the FDA, which until now had gone unresolved. Issuance of CFGs was directed by Congress in order to encourage exports of U.S. manufacturers to foreign countries, improving domestic commerce and providing jobs for U.S. citizens. I believe that the FDA has convoluted the intent of Congress by using the denial of CFGs as a punishment for companies allegedly not following FDA’s interpretation of the QSR, which in our case has been proven to be incorrect. We would have preferred that they simply talk to us about their concerns, especially since there was never an allegation of unsafe, ineffective or defective products.

Thankfully, UTMD was able to maintain its ISO certifications and CE Mark on its exported products continuously during the four-year dispute with the FDA. We hope, now that the court case has removed any legal justification for not talking, that the FDA will be open to constructive dialog to clear all past disagreements and establish a sound basis for future interaction.”

Utah Medical Products, Inc., with particular interest in health care for women and their babies, develops, manufactures, assembles and markets a broad range of well-established disposable and reusable specialty medical devices designed for better health outcomes for patients and their care-providers. For more information about Utah Medical Products, Inc., visit UTMD’s website at www.utahmed.com.
 
 

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