BioCurex, Inc.(fka BOCX)

[opportunityknocking]

Gold, wrong again. First, don't get upset when you see how the word is spreading. Look for yourself http://caninecancerblog.blogspot.com/

Second, get some more Visine.

How FDA Regulates Veterinary Devices


The Federal Food, Drug, and Cosmetic Act (the Act) defines medical devices as "an instrument, apparatus, implement, machine, contrivance, implant, in-vitro reagent, or other similar or related article, including any component, part, or accessory thereof, which is intended for use in the diagnosis of disease or other conditions; in the cure, mitigation, treatment, or prevention of disease in man or other animals; or which is intended to affect the structure or any function of the body of man or other animals." Further, a device "does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals, and is not dependent upon being metabolized for the achievement of any of its principal intended purposes." Examples of devices include such things as needles, syringes, surgical instruments, prosthetic devices, X-ray equipment, certain diagnostic test kits, and dental appliances.

Pre-market Approval is Not Required: The FDA does not require submission of a 510(k) or formal pre-market approval for devices used in veterinary medicine. Firms that manufacture radiation emitting devices need to register their products under the radiological health regulations, administered by the Center for Devices Radiological Health (CDRH).

Device manufacturers who exclusively manufacture, or distribute veterinary devices are not required to register their establishments and list veterinary devices.

FDA does have regulatory oversight over veterinary devices and can take appropriate regulatory action if a veterinary device is misbranded, mislabeled or adulterated.

It is the responsibility of the manufacturer and/or distributor of these articles to assure that these animal devices are safe, effective, and properly labeled.

FDA recommends that devices should meet or be equivalent to the performance standards. This is especially important devices that can be used both in humans and animals, such as examination gloves, sterile catheters, infusion pumps, etc.

FDA recommends that manufacturers and/or distributors of veterinary medical devices request a review of their product labeling and promotional literature to ensure that it complies with labeling and regulations. This includes devices marketed in another country and offered for importation into the U.S.

Third, you sitting down?

Consultations with the pertinent Government agencies in the USA and Canada indicate that neither the "homebrew" tests for veterinary use, nor the production facilities require regulatory approval.

Given the absence of regulatory delays as well as the fact that the technology is ready for use, the Company expects to take OncoPet(tm) to market within the next few months and to that effect, it has already registered the www.oncopet.net domain.

Fourth, and the knockout blow

Dr. Moro stated: "OncoPet(tm) is our response to generate revenue as quickly as possible. It is now ready for use and it requires no approvals that would excessively delay its launching. Marketing in North America is straight forward and the veterinarians we consulted are enthusiastic about the potential the test has to offer. Other markets such as Europe and Japan may be accessed via licensing or distribution agreements. OncoPet(tm) is now ready for use with dogs, but we anticipate it will also be as effective for cats, which approximately doubles the market size."

Sorry kid you are batting a thousand.......in being wrong. Yawn. Case closed.