Grapefruit USA Inc (GPFT)

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Lockedon6

Kingfisher7234 Share Sunday, February 27, 2011 9:29:45 AM
Re: None Post # of 38642

ALL: Here is a Letter from the FDA In response to my questions. This is why Dean cannot show the Dominion to shareholders. Read line 2 in the response very carefully.Only the FDA can clear for marketing! The emails have been posted in their entirety with the exception of my personal information being removed.

From: [e-mail]
To: xxxxxxxxxxxxxxx CC: [e-mail]
Date: Fri, 25 Feb 2011 16:29:49 -0500
Subject: 02-589 eje CDRA Devices

Dear XXXXXXXXXXXX,


Only items currently undergoing 510(k) review can be demonstrated or marketed. No promotion or advertising activities can be performed before the device has been cleared for marketing. Demonstrations of the device on television, video, the internet, or any other medium are considered to be marketing. The same is true of still print displays and other information about the device that is made available to the public.


You can have a display unit to show the shareholders. The display unit must be clearly marked with “For display purposes only” and “Not for human use.”


After your company submits a new 510(k) application for the device, you can display samples of the product at trade shows if the following conditions are met:

Samples/display devices for trade shows:

• The labeling on the device indicates that the device is for display purposes only and is not to be used on human subjects.

• The import paperwork should clearly indicate that the item is not for commercial distribution in the USA but for display purposes only, and

• The import paperwork should also indicate when the item will be sent back to the foreign company afterwards or otherwise disposed of.


Additionally, you can not market the device at trade shows before it has received 510(k) clearance from the FDA. Marketing includes distributing brochures, taking “pre-orders,” getting contact information from potential customers, etc.


If you need further assistance, please don’t hesitate to call DSMICA at 1-800-638-2041 or email us at [e-mail]. You may also call me at 301-796-5855. You can email me at [e-mail].


Cordially,


Eva Ellsworth




Eva Ellsworth
Consumer Safety Officer
Division of Small Manufacturers, International and Consumer Assistance
Center for Devices and Radiological Health
Office of Communication, Education, and Radiation Programs, US FDA
Phone: [phone]
Fax: [phone]

This response represents to the best of my judgment how the device should be regulated, solely based upon a review of the information you have provided. This response is not a classification decision for your device and does not constitute FDA clearance or approval for commercial distribution. Unless exempt from premarket notification submission (510(k)) requirements, the official classification for your device will appear on the final decision letter from any premarket review. All device types classified as exempt from the 510(k) requirements are subject to the limitations of exemptions. Limitations of device exemptions are found in the device classification chapters in 21 CFR xxx.9, where xxx refers to Parts 862-892 (e.g., 862.9, 864.9, etc.). Please be aware, if I have indicated that I believe your device falls within a device category classified as exempt from premarket review requirements, that it is your responsibility to ensure that you meet the exemption criteria and your device does not exceed the limitations of exemption. If your device exceeds the limitations of exemption, you must submit a 510(k) and receive a letter from FDA stating that your device may be commercially distributed in the U.S. prior to marketing your device.

This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.


You can now follow CDRH on Twitter at http://twitter.com/FDAcdrhIndustry

________________________________________
From: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
Sent: Thursday, February 24, 2011 12:43 PM
To: CDRH Small Manu. Assistance
Subject: CDRA Devices

Dear Sir

My questions concerns a radiological emitting devices. If a manufacture has produced a device but has not received SE, nor is currently enrolled in an active 510K or PMA application. Can the manufacture show the device being operated and producing images to the shareholders? Can they use the internet, TV, or video to show the device in real time use? Is showing the device in operation to the public considered marketing?

If there are regulations in place by the FDA to prevent this for what ever reason can you provide those documents?

The statement below was in the NSE letter to the company.

You may not Market this device until you provided adequaic information described above and required by 21 CFR 807.67 (J) and you have received a letter from the FDA allowing you to do so. If you market the device without conforming to these requirements you will be in violation of the Act.

Any help you can provide will be greatly appreciated.

Thank you
XXXXXXXXXXXXXXX
xxx-xxx-xxxx