Postmarket transformation roadmap coming soon
This article was originally published in The Gray Sheet
Executive Summary
The Center for Devices & Radiological Health is nearing completion of a detailed strategy to revamp the postmarket device safety program, according to Office of Surveillance and Biometrics Director Susan Gardner. The plan will include a prioritized list of areas where the device center aims to update and enhance its surveillance techniques. CDRH announced the postmarket transformation initiative in January, following an internal review of the current framework (1"The Gray Sheet" Jan. 23, 2006, p. 5). While there is no deadline for the document, Gardner says the team hopes to complete it by the end of June...