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Testing required from manufacturer in submission

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One of the differences between filing a Traditional 510k versus a Special 510k is the testing required from the manufacturer in the submission. The Traditional 510k requires all the testing to be provided to the FDA where the Special only requires a summary of the testing. Do you think this is a good idea to allow manufacturers to "police" themselves by only submitting summaries in a Special 510k ? Why or why not?

Reference no: EM133274668

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