Medical Devices
Medical Devices
A medical device is an instrument, apparatus, implant, machine, tool, in vitro diagnostic reagent, or similar article that is to diagnose, prevent, mitigate, treat, or cure disease or other conditions. During its life cycle, a medical device must go through various phases such as:
Concept and Design: The innovator works out the details for the design and manufacturing of the new device.
Clinical Trials: For some devices (generally class III but not the class I or II), clinical trials (studies that involve human participants) are conducted to test whether the device is safe and effective for its intended purpose.
Device review: The investigational device either undergo a review process by the FDA/EU or other regulatory bodies where a medical device is sold or is deemed exempt from review, depending on the device class and what types of similar devices are already on the market.
Device Clearance or approval: Devices that fulfill 510 (k) review process requirements are considered being “cleared.” Devices that meet the safety and effectiveness standards in the PMA process are considered being “approved”.
Post Market Monitoring: The FDA and other regulatory bodies continue to monitor both the side effects and the performance of the device after marketing, primarily by receiving reports of device malfunction or adverse events. Manufacturers also have post-market surveillance requirements specific to different device types.
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