FRequently Asked Questions

What is the abbreviated 510(k) program?

About the Author

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.

Read More >>

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.

‍