20/21 March 2024
The FDA has published an overview over the evolution of medical device recalls between the fiscal years 2003 and 2012. In 2010, the FDA started an initiative to improve recall processes in order to enhance public health. The report should thus help to increase understanding between the FDA and the industry in order to better protect the population against unsafe or limited useful medical devices.
Please find below some of the significant report outcomes:
For the CDRH, the report is part of a larger initiative to enhance public health. In this respect, the CDRH has taken different measures to improve the recall programme; among other things a systematic analysis of recall information, the establishment of a "Recall Process Improvement team", the integration of improved methods for reporting recall information to the stakeholders and improved internal processes to incorporate recall root causes in premarket reviews.
More information can be found in the Medical Device Recall Report.