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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
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.

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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