What is the abbreviated 510(k) program?


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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Proxima CRO Team
Dora Huang

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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