palani
7th December 2011, 06:59 PM
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm
If a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act it will be regulated by the Food and Drug Administration (FDA)4 as a medical device and is subject to premarketing and postmarketing regulatory controls. A device is:
* "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
o recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
o intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
o intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
Well, let's see. Pepper spray? Sure is intended to affect the function but it could be defined as a chemical action. How 'bout taser? This also affects the functioning of the body (stops it for a while) and doesn't require chemical action or being metabolized. Full metal jacket, shot gun, bean bag? Also affects the functioning of the body.
Suppose policymen be viewed in the role of medical practitioner? They sure carry around a lot of unlicensed medical devices and their diagnosis determines which of these devices they reach for.
If a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act it will be regulated by the Food and Drug Administration (FDA)4 as a medical device and is subject to premarketing and postmarketing regulatory controls. A device is:
* "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
o recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
o intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
o intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
Well, let's see. Pepper spray? Sure is intended to affect the function but it could be defined as a chemical action. How 'bout taser? This also affects the functioning of the body (stops it for a while) and doesn't require chemical action or being metabolized. Full metal jacket, shot gun, bean bag? Also affects the functioning of the body.
Suppose policymen be viewed in the role of medical practitioner? They sure carry around a lot of unlicensed medical devices and their diagnosis determines which of these devices they reach for.