What is a Medical Device?

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Medical Device Definition

A medical device is any instrument, apparatus, implement, machine, implant, in vitro reagent, or other related article which is intended for one of the following:

  • Diagnosis, cure, mitigation, treatment, or prevention of disease or other conditions
  • To affect the structure or any function of the body

A medical device does not achieve its primary intended purposes through chemical action within or on the body and is not dependent upon being metabolized for the achievement of its primary intended purposes.

Note: The definition or classification of medical devices will vary depending on the region and its governing body (e.g., U.S. Food and Drug Administration, EU Medical Device Regulation).

What is a Medical Device

FAQs

What is an example of a medical device?

Diagnostic ultrasound products, stethoscopes, catheters, x-ray machines, and medical lasers are some examples of medical devices..

*Source: https://www.fda.gov

What is the FDA definition of a medical device?

The FDA defines 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 an accessory that is:

  • Recognized in the official National Formulary, 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
  • Intended to affect the structure or any function of the body of man or other animals, and does not achieve its primary intended purposes through chemical action within or on the body of man or other animals

*Source: https://www.fda.gov

When is a device a medical device?

If a product satisfies the definition of a medical device as defined by Section 201(h) of the Food, Drug, and Cosmetic Act, it is considered a device and subject to FDA regulation.

*Source: https://www.fda.gov

Why does the FDA regulate medical devices?

The U.S. Food and Drug Administration (FDA) regulates medical devices to ensure their safety and effectiveness.

*Source: https://www.fda.gov

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