FDA Issues Draft Guidance for Device Industry and Staff for Postmarket Surveillance – Overview and Summary of Recommendations
Abstract:On August 16, 2011, the FDA issued draft guidance for the medical device industry and its own staff on how to conduct postmarket surveillance. This new guidance, when it is finalized, is expected to supersede the guidelines issued in 2006.
This article gives an overview of the new guidance and recommendations.
Compliance Trainings
Design History File (DHF), Device Master Record (DMR) and DHR Utilizing the Principles of Lean Documents and Lean Configuration
By - Jose Mora
On Demand Access Anytime
By - Jose Mora
On Demand Access Anytime
QA Agreements for ISO 13485:2019 and other Regulatory Compliance
By - Betty Lane
On Demand Access Anytime
By - Betty Lane
On Demand Access Anytime
Compliance Standards
You Recently Viewed
