What are the differences between Class I, II, and III devices?
An example of an AI chatbot conversation about the differences between Class I, II, and III medical devices.
What are the differences between Class I, II, and III devices?
Class I devices are low-risk, Class II devices are moderate-risk, and Class III devices are high-risk, requiring more regulation.
Can you give examples of each class?
Sure! Class I examples include bandages, Class II includes X-ray machines, and Class III includes pacemakers.
What kind of regulations do Class III devices face?
Class III devices must undergo rigorous testing and approval processes by regulatory bodies like the FDA before they can be marketed.
Are there any exceptions to these classifications?
Yes, some devices may be reclassified based on new evidence or technology, and there are also special pathways for certain devices.
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