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How do you determine substantial equivalence for a 510(k) submission?

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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.

It is first important to identify the predicate device and its trade name, model number, 510(k) submitter, and 510(k) number. Additionally, the sponsor must provide a detailed comparison between the two devices in terms of:

  • Indications for use
  • Technology
  • Performance specifications, including any testing

Within the executive summary, it is also necessary to describe both the device in question and the predicate device in appropriate detail. Typically, a table is used to summarize and compare various characteristics of the two devices in appearance and functionality.

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