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What is the abbreviated 510(k) program?
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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.

An Abbreviated 510(k) is used when there is an existing standard specific or guidance document that addresses the device classification.

Manufacturers may consider submitting an Abbreviated 510(k)when the submission relies on:

  • FDA guidance documents
  • Demonstration of compliance with special controls for the device type
  • Voluntary consensus standards

The average review time for this submission is 90 days.

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