Full Press Release Details
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
provisions of the Quality System Regulation (QSR). The certification
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.
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
compliance with current good manufacturing practice requirements for the
products listed above."
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
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
to CEO Kevin Cornwell,
to issue CFGs was the basis for the lawsuit that UTMD filed in June 2003
the FDA, which until now had gone unresolved. Issuance of CFGs was directed
Congress in order to encourage exports of U.S. manufacturers to foreign
countries, improving domestic commerce and providing jobs for U.S. citizens.
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.
would have preferred that they simply talk to us about their concerns,
especially since there was never an allegation of unsafe, ineffective or
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,
that the court case has removed any legal justification for not talking,
the FDA will be open to constructive dialog to clear all past disagreements
establish a sound basis for future interaction."
Medical Products, Inc., with particular interest in health care for women
their babies, develops, manufactures, assembles and markets a broad range
well-established disposable and reusable specialty medical devices designed
better health outcomes for patients and their care-providers. For more
information about Utah Medical Products, Inc., visit UTMD's website at