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How do you determine if an in vitro diagnostic (IVD) study is applicable for an IDE regulation?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

IVD studies are exempt from IDE regulation if:

  • The IVD is a pre-amendments device and is used or investigated according to the indications in the labeling at that time.
  • The IVD is a device that has been found to be substantially equivalent to a pre-amendments device.
  • The IVD is labeled, noninvasive, and…
    -    Does not require an invasive sampling procedure that presents significant risk,
    -    Does not by design or intention introduce energy into a subject, and
    -    Is not used as a diagnostic procedure without confirmation of the diagnosis by another diagnostic product.

If your IVD study does not fit into one of the three categories listed, then you must have an approved IDE prior to beginning your investigation and any shipment of your investigational IVD. The requirements for the IDE will depend on the level of risk that the study presents to its subjects.

Note: If your device has been approved under a PMA or cleared under a 510(k) and then used in a study in accordance to that labeling, it is not subject to IDE regulation.

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