The CDRH 510(k) Review Template: A Demo of the 510(k) Smart Template Used by CDRH Reviewers
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10/12/2017
When: 10/12/17
2pm ET
Where: United States
Contact: Sheri Devinney
202-354-7171


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On Thursday, October 12th at 2pm ET, MDMA will host an important, Member-Only (no cost) webinar, "The CDRH 510(k) Review Template: A Demo of the 510(k) Smart Template used by CDRH Reviewers to Review 510(k)'s", presented by Patrick Axtell, Program Operations Staff, Office of Device Evaluation, Food & Drug Administration.

This demo will begin with a brief description on how the Smart Templates were developed and are presently maintained, followed by a demo of the main characteristics and parts of the 510(k) Smart Template.  The demo will include a brief look inside the automated guides used by reviewers to review cross-cutting disciplines (e.g., Biocompatibility, Sterilization, Cybersecurity).  By the end of the demo you will understand how the template is used, how a single template can be used to review multiple device types, and what the components of the template are.