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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
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.

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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