A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved.
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Medical devices constitute a very huge and complex field. Devices can range from anything between a thermometer and a pacemaker. The FDA, the US' food and drug regulatory body, has a definition for
Health Equipment's. It considers a medical device as "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 its 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."
What is meant by FDA approval In Medical Devices
An FDA approval for medical devices means that the said product is ready and certified as being ready for marketing. Any and every manufacturer has to get FDA approval for marketing advice. It has to get this clearance through a premarket notification, or what is called 510 (K). The FDA will clear the device that has been sent to it for approval, or reject it. If the device meets the stringent criteria set by the FDA for approval, then it is considered an approved.
