R
FDA has a nice flow chart describing when to submit a new 510(k) vs. dealing with device/design changes by a "letter to file."
Is there an equivalent process or decision tree for 60601 testing?
Or another way to ask this question: device has been tested to 60601, some minor changes have been made. How can I decide whether these changes warrant another round of 60601 testing?
Is there an equivalent process or decision tree for 60601 testing?
Or another way to ask this question: device has been tested to 60601, some minor changes have been made. How can I decide whether these changes warrant another round of 60601 testing?
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