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Medical device manufacturing


Medical device manufacturing creates strict challenges from both an engineering and a legal perspective.

Medical devices are defined by the US Food and Drug Administration (FDA) as any object or component used in diagnosis, treatment, prevention, or cure of medical conditions or diseases, or affects body structure or function through means other than chemical or metabolic reaction in humans or animals. This includes all medical tools, excluding drugs, ranging from tongue depressors to Computerized Axial Tomography (CAT) scanners to radiology treatments. Because of the wide variety of equipment classified as medical devices, the FDA has no single standard to which a specific device must be manufactured; instead they have created an encompassing guide that all manufacturers must follow. Manufacturers are required to develop comprehensive procedures within the FDA framework in order to produce a specific device to approved safety standards. Devices are classified into three brackets: Class I: General Controls; Class II: General Controls and Special Controls; Class III: General Controls and Premarket Approval. Regulations differ by class based on their complexity or the potential hazards in the event of malfunction. Class I devices are the least likely to cause major bodily harm or death in the event of failure, and are subjected to less stringent regulations than are devices categorized as Class II or Class III.

General controls are the only controls regulating Class I medical devices. These state that a Class I medical device is "not intended to be:

Examples of Class I devices include bandages, bed-patient monitoring systems, medical disposable bedding, and some prosthetics such as hearing aids.

Class II devices are subject to stricter regulatory requirements than Class I devices. The additional requirements are called "special controls" and were established for cases in which patient safety and product effectiveness are not fully guaranteed by the previously stated general controls. Special controls are specific to each device and classification guides are available for various branches of medical devices.

Class III devices are those considered the most high-risk. These devices may be used in support or sustenance of human life, pose a potential risk of injury or illness, or are of great significance in preventative care. Prior to marketing such a device, the rights-holder(s) or person(s) with authorized access must seek FDA approval. The review process may exceed six months for final determination of safety by an FDA advisory committee. Many Class III devices have established guidelines for Premarket Approval (PMA), however with ongoing technological advances many Class III devices encompass concepts not previously marketed, These devices may not fit the scope of established device categories and do not yet have developed FDA guidelines.


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