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Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.
Applicable regulatory history, including the 510(k) number of the most recently cleared version of the device
Comparison of the modified device to the most recently cleared version of the device (consider including a table)
Applicable elements of this guidance, including the applicable questions from the body of the document
Analysis and assessment of the elements on this list and a conclusion of whether submission of a new 510(k) is required
Reference to related documents, particularly those that support the decision whether or not submission of a new 510(k) is required (e.g., risk analysis)