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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 regulation applies to research use only (RUO) or investigational use only (IUO) In Vitro Diagnostic (IVD) products?
Which regulations contain provisions relevant to in vitro diagnostic (IVD) devices?
What should be included in an abbreviated 510(k) submission?
Approved, Granted or Cleared – which term for what pathway?
What is the documentation required for a software-related submission?
What actions should you take if the change is made solely to return the system into specification of the most recently cleared device?
What devices does the FDA categorize as a SaMD, and how is clinical evaluation performed?
What types of certifications and statements must be included in a 510(k) submission?
What is the application process for devices intended for small patient populations subject to PMA?
What should you do if your device undergoes a material change?
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