Please Read all and respond, I would like as much input from Medical Professionals and students as
possible on this.
I am working on an appeal to the FDA in regards to a couple of products called MorningWell and
TravelWell.
These two products through sound and music relieve Emesis. The products are two cassette tape
programs which the "patient" uses with the use of a stereo or cassette player and headsets.
The program is listened to and it does three things
1. Grabs the Attention of the Vestibular nerve
2. "Educates" the vestibular nerve - tricks into believing the patient is not sick
3. Tells the Vestibular nerve to go back to its normal routine
The following is the FDA's definition of a medical device.
fda.gov312.htmlOpen ↗
We are wanting to bring this product to the U.S but are having a battle with the FDA - in that they
now believe our product to be a Class II Medical Device. The classes for medical devices are :
Class I - General Controls Class I devices are subject to the least regulatory control. They present
minimal potential for harm to the user and are often simpler in design than Class II or Class III
devices. Class I devices are subject to "General Controls" as are Class II and Class III devices.
Class II - Special Controls Class II devices are those for which general controls alone are
insufficient to assure safety and effectiveness, and existing methods are available to provide such
assurances. In addition to complying with general controls, Class II devices are also subject to
special controls.
Class III - Premarket Approval Class III is the most stringent regulatory category for devices.
Class III devices are those for which insufficient information exists to assure safety and
effectiveness solely through general or special controls.
We don't see how any class but Class I could be used for music. We are preparing a white paper on
sound and would happily provide this for your review and additional comments. If you would like to
read our review and make comments as a medical professional or a consumer as I am sure all have an
opinion email me at [email hidden] and we will send it to you. We would like to get your comments
back however no later than Jan 5th.
We are also looking for comments on the issue of the FDA breaking the law. Yes, they admitted they
broke the law in that they didn't provide us a decision in the legally required 60 days. Do you have
a comment on this - forward it to the email address above.
If you know other people that would like to add comment to our petition please forward this
posting to them.
Thank You very much for your assistance. Wayne Rowe