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Special 510k


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The Special 510k is used for device modifications under the design control aspects of the Quality System regulation (21 CFR Part 820.30).
- Special 510(k) may be submitted for a modification to a device that has been cleared under the 510(k) process.
- 510(k) holders will conduct the risk analysis and the necessary verification and validation activities to assure that the design outputs of the modified device meet the design input requirements.
- Basic content requirements of the 510(k) are available in 21 CFR 807.87
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