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:
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).
Diagnostic ultrasound products, stethoscopes, catheters, x-ray machines, and medical lasers are some examples of medical devices..
*Source: https://www.fda.gov
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:
*Source: https://www.fda.gov
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
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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