FDA lays out plans to improve post-market medical device oversight

The FDA today laid out plans for improving post-market medical device oversight, including a significant investment in its new National Evaluation System for health Technology. In an official posting, FDA head Dr. Scott Gottliebb and FDA Center for Devices and Radiological Health head Dr. Jeff Shuren laid out plans that they, and the agency, hope will address safety concerns that emerge after new devices hit the market and that will improve general overall safety in medical devices. To begin, the FDA said that it set an “ambitious new goal” in device safety: Ensuring that the FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices. The federal watchdog said that to attain this goal it will move beyond its existing post-market surveillance system, which it said is “largely passive and relies on device users to report problems to us,” into a new active surveillance system. The new system, which will operate around the FDA’s unique device identification system, will rely on real-world evidence and the “timely receipt” of safety information in an attempt to eliminate weaknesses inherent with the passive system, the FDA wrote. The agency said that as part of the development of a better post-market system, it is investing more resources in developing its National Evaluation System for health Technology, or NEST. “We’re now committing new resources to NEST to ad...
Source: Mass Device - Category: Medical Devices Authors: Tags: Featured Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news