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Regulations for Classification of Medical Devices in the United States?
Category:行業(yè)資訊 Date:2024-07-19 15:46:26 Author: Source:
Classification is determined by comparing a device to legally marketed devices and evaluating factors like intended use, technology, and potential risks. Regulatory requirements vary by class and include labeling, manufacturing standards, and post-market surveillance to maintain safety standards throughout the device's lifecycle.

The regulations for the classification of medical devices in the United States are based on risk assessment and intended use. Devices are categorized into three classes:

  1. Class I: Low-risk devices that do not require premarket approval. Examples include tongue depressors and elastic bandages.2(2).jpg

  2. Class II: Moderate-risk devices that require special controls to ensure safety and effectiveness. Most require a 510(k) premarket notification.

  3. Class III: High-risk devices that necessitate premarket approval based on scientific evidence demonstrating safety and effectiveness.

Classification is determined by comparing a device to legally marketed devices and evaluating factors like intended use, technology, and potential risks. Regulatory requirements vary by class and include labeling, manufacturing standards, and post-market surveillance to maintain safety standards throughout the device's lifecycle.

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