FDA warning letters to medical device manufacturers slid by nearly 90% between 2015 and 2019, but may be set to rebound upward in 2020, according to device center Associate Director for Compliance and Quality Erin Keith. Warning letters are used by FDA to alert a manufacturer it “has significantly violated FDA regulations,” such as misstating what a device is indicated for or having poor manufacturing practices, according to the agency.
Diana Zuckerman, president of the National Center for Health Research, said the trend is emblematic of a regulator that is overly focused on pleasing industry.
“It could have several different causes, reorganization could be one. [Medical Device User Fee Amendments] 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,” Zuckerman said.
Another method FDA has utilized is increasing the number of alternative methods of disseminating information, such as issuing Letters to Health Care Providers and Safety Communications. For example, in April 2019, the agency issued a safety communication alerting patients and providers of mammography problems at a medical clinic in Ohio, noting the facility “was unable to meet the parameters for a key quality control test on the day of the 2018 annual inspection.” FDA noted in the safety communication quality problems at East Palestine Family Medical Clinic dated back to October 2017, and recommended patients screened at the facility receive an additional mammography.
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