Thank you for visiting Any device that claims to affect the structure and function of the body is considered a n a Medical device b Technological device c Communication. This page is designed to guide you through key points and clear explanations related to the topic at hand. We aim to make your learning experience smooth, insightful, and informative. Dive in and discover the answers you're looking for!
Answer :
Final answer:
Any device that claims to affect the structure and function of the body is considered a medical device. This broad category includes everything from simple tools to complex technologies and is regulated by the FDA's CDRH, with over 6,000 types classified based on usage and impact on health.
Explanation:
Any device that claims to affect the structure and function of the body is considered a medical device. According to the definition provided by the FD&C Act, a medical device encompasses a wide range of products from simple tools like a Band-Aid and tongue depressor to complex implementations such as clinical testing kits and replacement hips. The classification of medical devices is determined by the FDA's Center for Medical Devices and Radiological Health (CDRH), where more than 6,000 types of medical devices have been regulated and classified based on their intended use and impact on the human body.
The correct answer to the question is: a) Medical device. This is because the defining characteristic of a medical device is its intention for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or its ability to affect the body's structure or function. Examples of medical devices that people might not commonly recognize include wearable computer devices like smartwatches and fitness trackers, which can monitor various health metrics and provide essential data regarding an individual's wellness.
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