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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 an architecture design chart?
What device investigations are subject to IDE regulation?
How can manufacturers identify and protect device assets and functionality?
What happens when the intended use of the proposed device is different from that of which appears on the labeling?
What are some common types of software changes?
What actions should you take if the change is made solely to strengthen cybersecurity and does not have any other impact on the software or device?
What are some other types of Q-Submissions?
How do you determine substantial equivalence for a 510(k) submission?
What regulation applies to research use only (RUO) or investigational use only (IUO) In Vitro Diagnostic (IVD) products?
What are the refuse to accept principles?
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