What is a Medical Device?

29 May 2013

The role of medical devices in healthcare is essential; however, defining what constitutes a medical device is not always as clear cut as it may seem.

Medical devices help save the lives of patients every day. The role of medical devices in healthcare is essential; however, defining what constitutes a medical device is not always as clear cut as it may seem.

For example, Medical Devices as defined by the FDA's Food, Drug and Cosmetic Act are instruments, apparatus, implements, machines, contrivances, implants, in vitro reagents, other similar or related articles, including any component, parts, or accessories, which are:

1. Recognized in the official NF/USP or any supplement to them;
2. Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man; or
3. Intended to affect the structure or any function of the body of man, and which does not achieve its primary intended purposes through chemical action within or on the body of man and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

Unlike in Europe and Canada, the FDA's definition does not specifically mention software. The European definition includes the phrase "including software necessary for its proper application...."

However, do not get fooled into thinking the FDA does not require software used in a medical device to be validated. They do require software to be validated.

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