FDA plans to overhaul medical devices approval process to improve patient safety | Luvera Law Firm Skip to content

FDA plans to overhaul medical devices approval process to improve patient safety

Responding to mounting pressure, the U.S. Food and Drug Administration (FDA) recently announced plans to overhaul its review and approval process for medical devices. The new protocol aims to ensure products reflect up-to-date safety features and standards to protect patients, after years of serious and sometimes fatal medical device-related safety issues.

This change is long overdue. The FDA’s decades-old system has been widely criticized by government watchdogs and independent medical experts for failing to catch or respond to known issues with defective or tainted devices.

The announcement was made shortly after the publication of a global investigation by the International Consortium of Investigative Journalists (ICIJ) into medical device safety. The report found that more than 1.7 million injuries and nearly 83,000 deaths allegedly linked to unsafe medical devices were reported to the FDA during a 10-year period.


Among its many findings, the ICIJ report discovered that when device manufacturers and health authorities around the world discover safety issues, there aren’t often protocols or requirements in place to report those problems to doctors or patients.

To help lead the charge on improving this issue, the FDA pledged to build an all-new communication and reporting system to ensure that the agency is “first among the world’s other regulatory agencies to identify and act upon safety signals related to medical devices.”

Additionally, the FDA may develop new regulations to help prevent manufacturers from pushing new products through the system and unleashing them on the market based on legacy regulatory approval of decades-old versions. Many medical devices have become increasingly complex and barely resemble the antiquated versions they claim to innovate upon.

The FDA may also consider phasing out some of these older devices entirely, so that new products can no longer reference them and will be required to undergo extensive clinical safety trials to enter the market.

We hope that the FDA’s plans to improve its approval system will help protect people from suffering preventable medical device injuries in the future.


If you or a family member have been injured due to a medical device issue, or if you have another legal issue you would like to discuss, we are here to help. You can reach us by phone: (206) 467-6090, or through our contact page.

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