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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

Jan 25, 2019

New FDA 510(k) Safety and Performance-Based Pathway Simplifies the Clearance Process for Well-Known Devices. Here’s How It Works.