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Medical Device Manufacturing: Associated Regulations

Few areas of engineering and manufacturing are held to a more rigorous standard or more heavily scrutinized than that of medical devices. The FDA generally defines medical devices 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 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."

This extremely broad category of products can include simple, versatile devices such a cotton swabs and tongue depressors to highly specialized and complex devices such as pacemakers and magnetic resonance imaging machines (MRI). Because of this enormously eclectic variety of devices, the FDA has no single standard to which a specific medical device must be manufactured; instead they have created an encompassing guide that all manufacturers must follow, and require each to develop their own comprehensive procedure in order to produce their specific device to the highest possible standards. Medical devices fall into three classes based on the risks associated with their proper use. Manufacturers of class 1 devices, those deemed to be “low risk”, are held to less ridged standards than manufacturers of high risk, class 3 devices. Nonetheless, the manufacturing process for even class 1 medical devices must adhere to the strict organizational structure set forth by the FDA Good Manufacturing Practice. This requires management comply with additional personnel training, organizational, and quality control standards above and beyond those expected for comparable non-medical devices.