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- Class I devices must comply with FDA's general controls, which include requirements for device registration, device listing, labeling, and adherence to Quality System Regulation (QSR) basic requirements (21 CFR Part 820).
- Design Features: Provide detailed descriptions of the device’s design, components, and materials used in its construction.
- Submission Timing: The FDA typically begins processing your 510(k) submission upon receipt. The clock starts when the FDA accepts your submission for review, which can take a few days to weeks after submission.
- Verify that your medical device meets the FDA classification criteria for Class I devices. Class I devices are generally low-risk and include items such as bandages, tongue depressors, and non-powered surgical instruments.
- Verify that your device meets the FDA classification criteria for Class I medical devices. Class I devices are generally low-risk and include items like bandages, tongue depressors, and non-powered surgical instruments.
- To prepare and submit a 510(k) premarket notification for FDA certification (clearance) of a Class I medical device, several key documents and information are typically required.
- 2024-08-05Confirm that your device meets the FDA classification criteria for Class I devices, which are generally low-risk and include items like bandages, tongue depressors, and non-powered surgical instruments.
- Start by registering your company and devices through FDA's FURLS platform. This system allows you to register your establishment and list your devices with the FDA.
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