FDA warning letters to devicemakers down nearly 90 percent

The number of warning letters the FDA sent to medical devicemakers fell by almost 90 percent between 2015 and 2019, and it could be because the FDA is too focused on pleasing the device industry, MedTech Dive reported.  

Warning letters are sent to devicemakers to flag when they've violated FDA regulations — anything from misstating what a device is indicated for to having poor manufacturing practices. 

In 2015, the FDA sent 81 letters to devicemakers. In 2019, the agency sent nine. 

The FDA has attributed the drop, in part, to restructuring in the department responsible for device regulation, Erin Keith, associate director for compliance and quality, told MedTech Dive

The department reportedly has made several changes in the last few years, such as requiring that warning letters be sent within 120 days of a physical inspection to make sure evidence is recent. 

The agency also has shifted focus from making sure devicemakers are simply complying with regulatory requirements to pushing them to make decisions that improve overall quality and patient outcomes. 

The goal is to have devicemakers address potential issues before reaching the warning letter stage, according to MedTech Dive.

Ms. Keith told MedTech Dive that now that the agency has had time to get comfortable with the new structure, the number of warning letters will likely begin to increase. 

But some patient safety advocates say the drop in warning letters isn't entirely because of the restructuring changes. 

"FDA is putting inadequate resources toward compliance oversight of the device industry," Public Citizen Director Mike Carome told MedTech Dive. "I think this reflects the industry-friendly approach to compliance oversight. Even when they do inspections, I think they seek ways to avoid issuing warning letters to protect the interests of industry."

Read the full article here

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