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FREQUENTLY Asked Questions
What should be included in documentation for device changes?
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About the Author
Isabella Schmitt, RAC
Director of Regulatory Affairs
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.
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Date of change assessment
Description of the device
Description of the change(s)
Reason why the change(s) is being made
Applicable regulatory history, including the
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
Reference to related documents, particularly those that support the decision whether or not submission of a new
is required (e.g., risk analysis)
What is a De Novo request and when are they used?
Does your software device qualify for a special 510(k) submission?
What is the application process for devices intended for small patient populations subject to PMA?
What are some common reasons as to why a 510(k) submission would not be accepted?
How does FDA classify medical devices?
What should be included in a binary qualitative test?
How can manufacturers identify and protect device assets and functionality?
What should IRBs do when reviewing the types of IVD studies that are the focus of this guidance?
What is included in a De Novo Pre-Sub?
What should you do if your device undergoes a technology, engineering, or performance change?
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