Ralph Fucetola JD
Newton, NJ 07860
973.300.1519
Memorandum
Date: 12/12/07
To: David Etheredge - Paradevices
Re: Questions Regarding Paradevices Products
You have asked for my recommended responses to three questions often raised by customers. I understand that your products are sold for water treatment purposes only and that your research shows that using the products with water does destroy pathogens in the water.
The questions you have asked, together with my opinions regarding same, are:
1. Does the FDA consider this product harmful?
FDA has not considered the product. It has not been submitted for FDA approval as it is not a ?medical device? within the meaning of the law. Under the applicable statute, 21 USC 360, generally, devices ?intended for human use?? must be registered, with certain exceptions, stated in the statute:
(l) Exemption from reporting requirements - A report under subsection (k) of this section is not required for a device intended for human use that is exempted from the requirements of this subsection under subsection (m) of this section or is within a type that has been classified into class I under section 360c of this title. The exception established in the preceding sentence does not apply to any class I device that is intended for a use which is of substantial importance in preventing impairment of human health, or to any class I device that presents a potential unreasonable risk of illness or injury.
Furthermore, the statute provides a definition of Class I devices:
(A) Class I, General Controls? (I) is not purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and (II) does not present a potential unreasonable risk of illness or injury?
It is my understanding that the product, sold to treat water not intended for drinking, is not ?for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and? does not present a potential unreasonable risk of illness or injury?? The intent of the product is to provide treatment of water by destroying pathogens present in the water.
2. Has FDA received any complaints about the ParaZapper.
I am aware of your FIOA request to FDA a couple years ago that showed no complaints on record with FDA and I understand that you have received no notices of complaints since then. There are no unresolved complaints from any customer.
3. If someone wanted to experiment with the product, to use in other ways, are they precluded by law from so using it?
No, any person may make any personal ?off label? use of any product offered in the market place. Generally, regulations by agencies such as the EPA, FDA and FTC apply to the companies selling the product and are based on the intended and advertised use of the product. These regulations do not impact how a customer uses the product after purchase.
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Respectfully submitted,