Postmarket Surveillance Issues for Medical Devices

Track:
Medical Devices, In Vitro Diagnostics, and Combination Products

Day & Time:
June 25, 8:00AM - 9:30AM

Session Number:
213

Room Number:
253C

Level:
Intermediate

Type:
Session

Title:
Postmarket Surveillance Issues for Medical Devices

Chair(s):
Kirsten H. Paulson
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.

Learning Objective(s):
Explain how FDA’s National Postmarket Strategy is being implemented; Discuss Device Registry Best Practices; Describe status of Postapproval Studies program and data transparency issues.

Presentation(s) & Speaker(s):
A Global Perspective on Strengthening the Postmarket Surveillance for Medical Devices
Colin R.W. Hayward, FFPM
Vice President, Medical Affairs
Premier Research Group, United Kingdom

Panelist
Kirsten H. Paulson
Senior Officer, Medical Device Initiative
The Pew Charitable Trusts, United States