FDA 510(k) Submissions

Aug 21, 2023

How to Transition Your Medical Device EUA to an FDA 510(k)

Aug 07, 2023

How Indications for Use Impact Medical Device Classification

Mar 22, 2022

What Happens When FDA Ends Medical Device and IVD Emergency Use Authorizations (EUAs)?

Feb 06, 2019

What to Expect After You Submit Your 510(k) Application to FDA

Feb 06, 2019

Digging In: Do You Have the Data Needed to Support a Successful FDA 510(k) Submission?

Feb 06, 2019

The FDA 510(k) Process: Setting the Stage for a Successful Submission and Faster Approval