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Thursday, March 28

NEW Special FDA Session: Historical Glance and Approval Process Overview

Participants Physicians and healthcare professionals using medical devices for patient care and clinical research.

Background Requirements No prior regulatory knowledge should be required to achieve the learning objectives of this course.

Educational Needs/Expected Learning Objectives Attendees will gain an understanding of the FDA approval process for selected medical devices and therefore improve their ability to properly advise and consent patients. They will also learn how they can use and advertise their medical devices consistent with FDA cleared labeling.

Dieter Manstein, MD, PhD Manstein-Dieter-Thumb
Richard P. Felten, BA, MS Felten-Richard-P-Thumb
Shlomit Halachmi, MD, PhD Halachmi-Shlomit-Thumb
Time Title - Presenting Author
12:15 PM - 12:18 PM Introduction and Pre-Test - Dieter Manstein
12:19 PM - 12:39 PM Historical Glance of the FDA Approval Process - Richard P. Felten
12:40 PM - 12:45 PM Q&A
12:46 PM - 1:06 PM Overview of Current FDA Approval Process - Shlomit Halachmi
1:07 PM - 1:12 PM Q&A
1:13 PM - 1:15 PM Conclusion and Post-Test - Dieter Manstein

CME Max AMA PRA Category 1 CME Credits™, CE Max CE Contact Hours

aslms-2019-novice-icon Novice | aslms-2019-intermediate-icon Intermediate | aslms-2019-expert-icon Expert

Schedule and rooms subject to change without notice

The American Society for Laser Medicine and Surgery, Inc. is the world’s largest scientific organization dedicated to promoting research, education and high standards of clinical care in the field of medical laser applications. It provides a forum for the exchange of scientific information and participation in communicating the latest developments in laser medicine and surgery to clinicians, research investigators, government and regulatory agencies, and the public.

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