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How are medical devices classified in the United States?
Category：行业资讯 Date：2024-07-31 17:26:18 Author: Source:
The classification of medical devices helps ensure appropriate regulatory oversight based on their potential risks, thereby safeguarding public health while facilitating timely access to innovative medical technologies. Each class has specific regulatory requirements that manufacturers must fulfill to bring their products to market in compliance with FDA regulations.

In the United States, medical devices are classified into three main categories based on the level of control necessary to ensure their safety and effectiveness. This classification system is overseen by the FDA (Food and Drug Administration) and is primarily determined by the device's intended use, potential risks to the patient, and the regulatory requirements applicable to each class.2(1).jpg

  1. Class I Devices: These are considered low-risk devices and are subject to the least regulatory controls. Examples include simple devices like tongue depressors, elastic bandages, and non-powered surgical instruments. Class I devices are often exempt from the need for premarket notification or FDA clearance before marketing, though they must still comply with general controls.

  2. Class II Devices: These devices pose moderate risks to patients and typically require special controls to provide reasonable assurance of safety and effectiveness. Examples include powered wheelchairs, infusion pumps, and surgical drapes. Class II devices are subject to FDA clearance before they can be marketed. The clearance process usually involves demonstrating substantial equivalence to a legally marketed predicate device.

  3. Class III Devices: These devices present the highest risk to patients and are subject to the most stringent regulatory controls. Examples include implantable pacemakers, coronary stents, and HIV diagnostic tests. Class III devices require FDA approval of a premarket approval (PMA) application before they can be marketed. Approval involves demonstrating the device's safety and effectiveness through clinical data and other scientific evidence.

The classification of medical devices helps ensure appropriate regulatory oversight based on their potential risks, thereby safeguarding public health while facilitating timely access to innovative medical technologies. Each class has specific regulatory requirements that manufacturers must fulfill to bring their products to market in compliance with FDA regulations.

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