MEDx Medical Usage Restrictions Agreement

After reading this letter, please send us a signed copy of this letter via fax or postmark. Our fax number is (703) 437-1725. This form must be received before we can issue a permanent license for your MEDx software.

A printable version is available here.

We wish to thank you for your past support and continued usage of the MEDx medical image visualization and analysis program for UNIX workstations. We have many future plans for the product, and we will advise you through the appropriate channels as these enhancements become available.

At the same time, however, we wish to remind you that the MEDx product is "for research use only" or "for investigational use only." The Department of Health and Human Services (DHHS) National Institute of Health (NIH) defines "research" as...

" ... a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge... " (Cf. 45 CFR 46.102(d))

The "human subject" in research is...

" ... a living individual about whom an investigator... conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between the investigator and subject... " (Cf. 45 CFR 46.102(f))

Similarly, the DHHS Food and Drug Administration (FDA) defines an "investigation" as...

"... a clinical investigation or research involving one or more subjects to determine the safety or effectiveness of a device... " (Cf. 21 CFR 812.3(h))

The FDA definition of a "subject" is...

" ... a human who participates in an investigation, either as an individual on whom... an investigational device is used or as a control. A subject may be in normal health or may have a medical condition or disease... " (Cf. 21 CFR 812.3(p))

Within this regulatory framework, then, a clinical investigation can be argued to be a more restrictive form of research, in which the data and information collected are intended to be used to support the claims of a device's safety or effectiveness (the FDA regards software used in medical applications to be a medical device).

At the present time, Medical Numerics makes no representation that the MEDx product is either safe or effective for any intended use for which research may currently be performed.

If you are conducting research or clinical investigations, then by law you are required to obtain prior Investigational Review Board (IRB) approval of the clinical study protocol and of the patient informed consent documents, and to provide each patient/subject with a copy of the completed informed consent document. Similarly, if you are conducting research or clinical investigations using animal subjects, you are obligated to follow Good Laboratory Practices, and to observe the ethical treatment of the animals. If your facility or academic institution receives funding from NIH, or if your IRB has DHHS-approved assurances on-file, then you are obligated to follow the NIH rules, in addition to the FDA rules.

As a consequence of the regulatory status of the MEDx product, you are reminded of the Login Acceptance Screen, reprinted below, in which you acknowledge the regulatory status of the product prior to using its functionality:

You are encouraged to contact your governing IRB or clinical risk manager should you have any additional questions or concerns. We hope that this information clarifies your understanding of the regulatory status of the MEDx product, and look forward to continued dialog with you.

To acknowledge the conditions regulating the use of MEDx, please sign this letter in the space provided below and fax a copy to us at (703) 437-1725.

We wish you continued success in your research activities.

I agree to the above restrictions on the use of MEDx.

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Customer's Signature

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Customer's Name (Printed)

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