What is the abbreviated 510(k) program?

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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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About the Author
Proxima CRO Team
Dora Huang
Intern

Dora Huang is from Houston, TX and is a jack-of-all-trades. Dora is a Regulatory Affairs and Graphics Design Intern for Proxima. She has experience working on projects that vary from engineering water systems to tissue engineering.

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