GAO finds gaps in the US FDA medical device recall procedures
This article was originally published in RAJ Devices
Executive Summary
The US Food and Drug Administration's procedures for overseeing medical device recalls are unclear and represent a missed opportunity for the agency to proactively identify and address risks presented by unsafe devices, the Government Accountability Office has said in a report1.
You may also be interested in...
Global Pharma Guidance Tracker – March 2024
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
EU Regulators Explain How To Ensure Transitioned Trials Align With CTR
Members of the EU’s Clinical Trials Coordination Group have developed harmonized requirements for updating trials that are transitioned to the Clinical Trials Information System based on a minimum set of documents.
Global Medtech Guidance Tracker: March 2024
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Fifty-nine documents have been posted on the tracker since its last update.