MassMEDIC Webinar: CDRH Reviewer Software: An inside look at the 510(k) Smart Template used by reviewers in the Office of Device Evaluation (ODE) when reviewing 510(k)s.

When: « Back to Calendar June 26, 2017 @ 12:00 pm - 2:00 pm
Where: Webinar
Categories: MassMEDIC Events

 

Please join this live MassMEDIC webinar as Patrick Axtell, Policy Analyst, Office of Device Evaluation, FDA, provides the first-ever demonstration of FDA’s Smart Template Software.

Who: CDRH: Patrick Axtell, Ph.D.; Mass Medic: Tom Sommer President; Right Submission: Juan Carlos Serna, President.

What: A free web seminar where FDA will walk participants through the 510(k) Smart Review Template used by ODE reviewers when reviewing 510(k)s.

When: June 26th, 12-2:00 p.m. (ET)

Where: Free Webinar – register here.

Why: By participating, you will get an inside look the 510(k) Smart Template, giving you the opportunity to see the guide reviewers use when reviewing a 510(k).  This will include a description on why the template was developed, an overview of the design purposes, as well as demonstrations of multiple parts of the template.