The following four areas were designated for improvement. They are:
|
"Report of the Postmarket Transformation Leadership Team: Strengthening FDA’s Postmarket Program for Medical Devices" which provides an action plan for changes to the medical devices postmarket program. (November 2006) |
|
|
|
Questions & Answers - External Audience (November 2006) |
|
|
|
Press Release (November 2006) |
|
|
|
Ensuring the Safety of Marketed Medical Devices: CDRH’s Medical Device Postmarket Safety Program, which documents the postmarket inventory and discusses the CDRH postmarket program. (January 2006) |
|
|
|
A separate Synopsis and Recommendations document provides a list of initial action steps the Center will take to strengthen postmarket effectiveness. (January 2006) |
|
|
|
A presentation titled "Ensuring the Safety of Marketed Medical Devices" by Dr. Daniel Schultz, Director, Center for Devices and Radiological Health (January 4, 2006) |
|
|