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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

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.

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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