Enhancing post-market safety

Ashton Steinhagen, lead clinical research associate for IMARC Research, Inc. The FDA released a follow-up statement to their “Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health” release that was unveiled in April 2018.  The focus was expanding on post-market surveillance for medical devices. In this plan, the main objectives were to promote and improve public safety and detect safety risks earlier while keeping all those involved, including physicians, informed.  The plan specifically focuses on these five points. Establish a robust medical device patient safety net in the United States Explore regulatory options to streamline and modernize timely implementation of post-market mitigations Spur innovation towards safer medical devices Advance medical device cybersecurity Integrate the Center for Devices and Radiological Health’s (CDRH’s) premarket and post-market offices and activities to advance the use of a TPLC approach to device safety. Since this release, the FDA noted that they will update their plan with hopes of their new goal of ensuring that the FDA is “consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices” is met.  A few approaches that the FDA will undertake to achieve this goal would be the focus of new technologies and new tools. The FDA noted that while their current post-market system in place helps achieve some of the objectives, the system ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog IMARC Source Type: news