DIA 2013 49th Annual Meeting
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Postmarket Surveillance Issues for Medical Devices
Track
:
Track 09: Medical Devices, In Vitro Diagnostics, and Combination Products
Program Code:
213
Date:
Tuesday, June 25, 2013
Time:
8:00 AM to 9:30 AM
EST
Location:
253C
CHAIR
:
Kirsten H. Paulson, (SCHSUP), Senior Officer, Medical Device Initiative, The Pew Charitable Trusts, United States
SPEAKER
(S):
Colin R.W. Hayward, FFPM (SPKNON), Vice President, Medical Affairs, Premier Research Group, United Kingdom Kirsten H. Paulson, (SPKSUP), Senior Officer, Medical Device Initiative, The Pew Charitable Trusts, United States
Description
FDA's CDRH released a draft National Postmarket Strategy in September 2012, outlining major areas of focus for the postmarket program. This session will look at the scope of the strategy document and status, provide an overview of the Postapproval Study program and look in detail at one of the pillars of the new strategy — medical device registries.
This session is a part of:
This session is a part of: