Abstract
While there is some blurring along the edges, the definition of a medical device is fundamentally a product with a therapeutic effect or application that does not depend on interaction with the body chemically or metabolically. In vitro diagnostics are which test samples taken from the body and radiologic contrivance (such as X-rays, ultrasound devices, MRIs and such), which use energy prom outside the body for either diagnostic or therapeutic purposes, are regulated as devices. Regulations as to what testing must be alone (prior to exposure of patients to a device) have been very much harmonized for major markets (the United States, Europe, Japan, China, and many others) by the adoption of ISO (International Standards Organizations) guidelines though there are variations in how such testing is evaluated and interpreted. The key elements are the novelty of the device and its constituent materials (expressed by classifying a device as Class I, needs minimal premarket testing, to Class II, extensive nonclinical and then clinical testing is required) and by the type and duration of patient contact.
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Notes
- 1.
CEN BTS 3/WG 1—Risk Analysis is available through the British Standards Institute.
- 2.
Available from the Association for the Advancement of Medical Instrumentation, 3330 Washington Blvd., Ste. 400, Arlington, VA 22201.
- 3.
Draft copies of the Medical Device Paradigm may be obtained by contacting Dr. Melvin Stratmeyer, FDA Center for Devices and Radiological Health, HFZ-112, Division of Life Sciences, Office of Science and Technology, FDA, Rockville, MD 20857.
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Gad, S.C. (2019). Regulatory Aspects and Strategy in Medical Device and Biomaterials Safety Evaluation. In: Integrated Safety and Risk Assessment for Medical Devices and Combination Products. Springer, Cham. https://doi.org/10.1007/978-3-030-35241-7_2
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