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By FDA Regulation a Component or Accessory to a Medical Device is a Medical Device
This can be a difficult part of the regulation to fully grasp and apply. Mainly because there are a lot of factors that add to the complexity of the issue.
The medical device definition provided by the FDA is useful when distinguishing differences between products such as pharmaceuticals, however falls short of defining the subtle inferences of components and accessories on the overall device.
In the US the FDA defines “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:
recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, 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 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."
By US law, any manufactured good that is a component of or an accessory to a medical device, is in itself - a medical device. FDA rules state that unless separately classified, a component, parts or accessory to a medical device is regulated in the same way as its parent device.1