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DIA 2013 49th Annual Meeting
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How to Convert a New Device (PMA) into an Old (510(k)) Device: The De Novo 510(k)
Track : Track 09: Medical Devices, In Vitro Diagnostics, and Combination Products
Program Code: 312
Date: Wednesday, June 26, 2013
Time: 8:00 AM to 9:30 AM  EST
Location: 253C
CHAIR :
 Michael A. Swit, Esq, JD (SCHNON), Special Counsel, Duane Morris, LLP, United States
SPEAKER (S):
 Michael A. Swit, Esq, JD (SPKNON), Special Counsel, Duane Morris, LLP, United States
Michael Drues, PhD (SPKNON), Founder and President, Vascular Sciences, United States
Description
Under the 1976 Device Amendments, new technology that is not substantially equivalent to a marketed device is automatically put in Class III. This session reviews how to get that class switched to a less risky, less expensive regulatory path.

Session Recording
(Code: 312)
DIA 2013 Attendee:
Attendees Login
  
This session is a part of:
DIA 2013 Live Learning Center
CON4 Comp Access: Wednesday Online Access Package - June 26, 2013
Handout Online
(Code: 312)
DIA 2013 Attendee:
Attendees Login
  
This session is a part of:
DIA 2013 Live Learning Center
CON4 Comp Access: Wednesday Online Access Package - June 26, 2013
How to Convert a New Device (PMA) into an Old (510(k)) Device: The De Novo 510(k)