Don't over think regulation for this, it's pretty easy: there is a big huge government system that you grew up with that spells this situation out very explicitly. 

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However, there are two or more things happening at once that this page will explain:

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First:

Intratumor injection (ITI) of any kind of therapy, including the ITI of any electrochemically activated chemotherapy molecule and or regiment, is regulated at point-of-care through the point-of-contact primary care provider and their laws of governance, just like all the other medical and or surgical procedures that exist, this doesn't change.

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Second:

Electrochemically activated chemotherapy (EAC) is a previously disclosed technology: i) realized, ii) defined, and iii) created by Jordache Boudreau, not Innovative Potential. EAC itself is not patentable because it is an applied  natural electrochemical phenomenon, the judgement for this ruling is found in the example of the electrochemical detector of a high-pressure liquid chromatographic instrument: it is the same principle and chemistry at work as EAC; just, applied with a different intended endpoint. Equipment for the development of EAC-classed molecules is essentially unregulated and commercially available world wide. However: specific technological hardware emobodiments for EAC applications are patentable (see: Publications Page).

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Third:

The chemotherapeutic galvanostat/potentiostat (CGP) is a specific and legally defined patented technology (WO: 019028560; CA: 3035406; U.S.: 11198943); and, all CGP embodiments, as invented by Jordache Boudreau, are property of Innovative Potential.

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In Canada and the United States of America: you need explicit written permission from Innovative Potential for use of any and all CGP embodiment(s).

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The CGP is first in its categorical class world wide. The CGP is able to perform the duties and services detailed and required by EAC; and, in some embodiments: is able to apply ITI directly as a regulated medical device.

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Fourth:

EAC hardware and CGP hardware are regulated as electronic hardware, separately from each other, within each nation's jurisdictions.

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Fifth:

All CGP are electronic, but only some CGP embodiments are medical devices. No EAC hardware directly meets the requirements of a medical device, and are only suitable for molecular development research purposes. EAC hardware is not clinically and or medically viable hardware. The Patents authored by Jordache Boudreau were the first laws that distinguished EAC hardware from CGP hardware, and further distinguished the CGP embodiments into medical CGP and non-medical CGP device classifications.

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Sixth:

Each nation has a classification system for the categorization, determination, and regulation of medical devices. Specific CGP embodiments, like The Joey™, are medical devices. The Joey™ CGP is considered to be classifiable as a Class III (Canada) or Class IV (U.S.A.) medical device.

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Seventh:

EAC-classed molecules and EAC-formulations are regulated, separately from EAC and CGP hardware, as application dictates, within each nation's own molecular regulatory frameworks and jurisdictions.

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Eighth:

All electrochemically activated chemotherapy (EAC)-classed molecules and EAC-formulations are categorized as a specific sub-class of electrochemically activated (ECA)​ molecules. All CGP hardware is expected to be compatible with most ECA-classed molecules and ECA-formulations.