Quantum field EMF clearing devices and FDA registration

Not all firms claiming to have FDA medical device registration may be in compliance.

And the FDA does not expressly say that it regulates quantum devices. However, some of these technologies could require FDA registration. This is a tricky legal area, in which our law offices has expertise.

Meanwhile, here is an interesting take from a company manufacturing or distributing quantum technologies:

Many of the firms referenced in this section claim that they or their products are registered with the FDA. However, simple searches that anyone can do in relevant FDA website databases show no filings with the FDA in many or most of the cases. Just go to the homepage of the FDA Center for Devices and Radiological Health website (www.fda.gov/cdrh/index.html) and click on "Databases" on the right side of the homepage. You can then search in the Establishment Registration, Device Listing, Premarket Notification (510(k)) and Premarket Approval databases, among others, by entering the name of the product and/or its manufacturer in the appropriate search fields).

We searched these four databases and found no matching results for the following firms and/or "feedback," bio-informational or bio-energy products:
QXCI, SCIO, BICOM, Oberon, e-Lybra, NES, radionic, Copen, and Quantec.

Is this not surprising?

A misconception of the actual legal marketing status of a product can arise when a company says that its system has been "registered" with the FDA (possibly denoting marketing approval or clearance in the minds of those unfamiliar with FDA terminology and processes) when in actual fact the company has only filed an "establishment registration" and/or a "medical device listing" with the FDA. Such a filing is no more than filling out a one-page administrative form and paying a fee in the case of establishment registration.

However, establishment registration and medical device listing do not mean the FDA has approved or cleared a product for marketing as a medical device or found it to be safe and effective for its intended uses. For example, Ondamed appears to have establishment registrations for two sites and a medical device listing for a biofeedback device, but not FDA marketing clearance or approval for a medical device, according to the website records of the FDA. There also are other general controls with which firms must comply for legal marketing of a medical device - labeling, adverse event reporting and current good manufacturing practice requirements.

Some version of the EPFX product got a 510(k) clearance (FDA marketing authorization) almost 20 years ago. Most people do not even know that Bill Nelson produced the EPFX before the QXCI and SCIO. Of course it is not produced any longer and the clearance was only received for gathering skin resistance, voltage and temperature data for use in stress reduction/relaxation training and no other claim.

However, the manufacturer of the current QXCI and SCIO products has now started to always advertise the products in conjunction with mentioning EPFX. Of course QXCI and SCIO are simply different products and do not have their own FDA marketing clearances.

But what about the Inergetix-CoRe System?

We are working with our FDA lawyers to assess whether device recognition is possible for our product and hope that we will be able to break new ground. However, it is important that everyone involved is aware of certain facts. The FDA has no category for BIORESONANCE, let alone INFORMATIONAL MEDICINE. These terms are not found upon doing a search of the entire FDA database. This fact of course makes clear what an enormous challenge any company would face attempting to get a "marketing approval or clearance" for this type of device, despite being used for over half a century all over the world on thousands of clients and being manufactured by dozens of companies.

In the interim, we are also considering development of a biofeedback device classifiable to FDA regulation 21 C.F.R. § 882.5050.

It is clear that the times are changing, and maybe the time will come when bioresonance and informational medicine devices are recognized and approved by the FDA, but we first have to give up the idea that the FDA is our enemy. We also have to be honest towards our client and make them aware that use of the CoRe System and similar systems is not a cure-for-all and that traditional healthcare practitioners have their place (just as holistic practitioners do).

So again it comes down to honesty and cooperation.

... In this spirit I hope you will not see the pages in this section as an attack on anyone, but instead as an attempt to bring highly needed light and information to the whole subject of FDA regulation.

Kiran Schmidt
-Director of Inergetix, Inc.-

The most interesting comment here is that: "The FDA has no category for BIORESONANCE, let alone INFORMATIONAL MEDICINE. These terms are not found upon doing a search of the entire FDA database. This fact of course makes clear what an enormous challenge any company would face attempting to get a "marketing approval or clearance" for this type of device."

A 513(g) letter may be part of the answer. Our law office can address this as well as other legal strategies. Remember that one warning letter, import alert or other enforcement action from the FDA can stop a business in its tracks, so it is useful to map out a legal strategy ahead of time.

Law Offices of Michael H. Cohen.