DEVICE EXEMPTION Meaning and
Definition
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Device exemption refers to an exception or exemption granted to certain medical devices by regulatory authorities such as the Food and Drug Administration (FDA) in the United States. A device exemption allows a medical device manufacturer to bypass the usual stringent requirements and regulations for safety and efficacy that are typically applied to medical devices before they can be marketed and sold.
This exemption is generally granted when a medical device is considered to have low risk or when its approval process would impose undue burdens on both the regulatory body and the manufacturer, without providing significant benefits to public health. The process of obtaining a device exemption involves submitting an application to the regulatory authority, providing detailed information about the device's intended use, design, and expected performance.
Devices granted exemption are often those that have a long history of safe and effective use, are considered to be well-understood, or are of a relatively low-risk nature, such as certain diagnostic test kits or simple surgical instruments. However, it is important to note that device exemption does not mean that the device is completely unregulated. Manufacturers are still required to comply with certain quality control and manufacturing standards. The device exemption is intended to streamline the regulatory process while ensuring public safety and promoting access to medical technologies that offer minimal risk.
In summary, a device exemption is a special permission granted by regulatory authorities that allows certain medical devices to be marketed and sold without undergoing the usual regulatory scrutiny, typically because they pose low risk and have a long history of safe use.
Common Misspellings for DEVICE EXEMPTION
- sevice exemption
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Etymology of DEVICE EXEMPTION
The etymology of the word "device exemption" can be broken down as follows:
1. Device: The word "device" comes from the Latin word "devicium", which means "device, plan, or contrivance". It ultimately derives from the Latin verb "dividere", meaning "to divide or separate".
2. Exemption: The word "exemption" comes from the Latin word "exemptio", which means "immunity" or "exemption from duty or service". It is derived from the Latin verb "eximere", meaning "take out" or "free from".
When combined, "device exemption" refers to a situation where a particular device is exempt or excluded from certain regulations or requirements.
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