|When:||« Back to Calendar June 26, 2017 @ 12:00 pm - 2:00 pm|
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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.