Devices

FDA Device Warning Letters May Increase: Keith

CDRH associate director for compliance and quality Erin Keith says the number of Warning Letters issued by the Center may start to climb this year as reorganization bugs that prevented sending letters on time are worked out. However, not all observers agree that reorganization is the only cause for a significant drop in Warning Letters.

Keith was quoted in a MedTech Dive online report that the drop from 81 letters in FY 2015 to nine in 2019 came during a major reorganization that proved “very disruptive to the compliance office.” She told a 12/2019 Food and Drug Law Institute conference that the office is organized in a different way now than it was in the past, and said the processes have had to be worked out.

FDA Office of the Chief Counsel told CDRH that letters should be issued within 120 days of a physical inspection of a manufacturer to ensure that the underlying evidence is fresh. Keith told MedTech Dive that Center employees are more familiar now with the new structure of the CDRH “super office” and so the number of Warning Letters should increase.

Questioning how much of a role the reorganization played, Public Citizen Health Research Group director Mike Carome said the downward trend cannot be adequately explained by the agency internal changes. And National Center for Health Research president Diana Zuckerman said the trend is emblematic of a regulator that is overly focused on pleasing industry.

“It could have several different causes,” Zuckerman said. “Reorganization could be one. MDUFA regulations could be part of it, which requires more meetings. But there is this emphasis on customer service, which is defined as making life easier for the industry. Industry is an important customer, but so is the American taxpayer.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome