JD Supra

FDA Launches eSTAR Pilot Program to Further Simplify Medical Device 510(k) Submissions

In what appears to be another electronic tool in the US Food and Drug Administration’s quest to move to full digital submissions for medical devices, the eSTAR program provides 510(k) applicants with ...
JD Supra

FDA Issues Final Guidance on "Deciding When to Submit a 510(k) for a Change to an Existing Medical Device"

Recently, the U.S. Food and Drug Administration (FDA) issued final guidance on deciding when to submit a new 510(k) premarket notification application for a change to an existing medical device. 1 The ...
MD&M East

4 Tips for a Smooth 510(k) Submission Process

An expert shares four things he's learned about the 510(k) submission process that you can use to your advantage. Jon Speer As you are probably aware, a 510(k) submission is required in order to get ...
Nasdaq

AirXpanders® Announces Special 510(k) Submission to the US FDA for a Smooth Shell Version of the AeroForm® Tissue Expander System

SAN JOSE, Calif., May 13, 2019 /PRNewswire/ -- AirXpanders, Inc. (ASX: AXP), a medical device company focused on the design, manufacture, sale and distribution of the AeroForm® Tissue Expander System, ...