Letter to Medimpex United Inc.
DEPARTMENT OF HEALTH & HUMAN SERVICES |
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Food and Drug Administration
2098 Gaither Road
Rockville MD 20850
DEC 1 2003
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President and CEO
Medimpex United Inc.
940 Pennsylvania Boulevard, Unit F
Feasterville, PA 19053
Dear Sir or Madam:
We are writing to you because the Food and Drug Administration (FDA) has reviewed
information revealing a possible regulatory problem with the sample collection
system offered for sale by Medimpex United Inc. (Medimpex) as part of the company's
"Hair Follicular Drug Test" (see http://www.meditests.com/hairdrugtest.html).
Based on promotional material on your website, it appears that you offer for
sale collection systems intended for use in collecting hair follicle samples,
which are then sent to you to test for the presence of drugs of abuse.
Under the Federal Food, Drug, and Cosmetic Act (the Act), an over-the-counter
(OTC) test sample collection system for drugs of abuse testing is a device because
it is intended for use in the diagnosis of a disease or other condition, or
in the cure, mitigation, treatment, or prevention of disease (section 201(h)(2)
of the Act). FDA regulations establish certain requirements for OTC sample collection
systems used to collect biological samples, such as hair, urine, saliva, sweat,
or other matrices, that are then tested for drugs of abuse (Title 21 Code of
Federal Regulations 809.40, 864.3260). These regulations require that, among
other things, the screening test used on the collected samples be approved,
cleared, or otherwise recognized by FDA as accurate and reliable. Failure to
adhere to this requirement would render the OTC test sample collection system
misbranded under section 502(q)(2) of the Act.
Our records indicate that the drugs of abuse screening tests you are performing
on hair samples obtained using your sample collection system have not been cleared,
approved, or otherwise recognized as accurate and reliable by FDA. We also note
that the information on your website about the hair follicular drug test includes
a statement that "[a]ll tests are FDA approved." As explained above,
our records do not show that any Medimpex test using hair as the relevant matrix
has been approved or cleared by FDA. Thus, this statement is false and renders
these devices misbranded under section 502(a) of the Act.
There are many FDA requirements pertaining to the manufacture, distribution,
and marketing of devices. You may obtain general information about these requirements
by contacting our Division of Small Manufacturers, International and Consumer
Assistance (DSMICA) at 1-800-638-2041 or through the Internet at http://www.fda.gov.
You may provide information or direct any questions you may have to Steven
Gutman, M.D., Director, Office of In Vitro Diagnostic Device Evaluation and
Safety, Center for Devices and Radiological Health, 2098 Gaither Road, Rockville,
Maryland 20850, (301) 594-3084.
Sincerely yours,
/S/
Steven I. Gutman, M.D., M.B.A.
Office Director
Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health
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