FDA Issues Warning Letter to Battelle Memorial Institue

On October 7 the FDA issued a warning letter to Battelle Memorial Institute for failing to comply with regulatory requirements for medical device reporting.

According to reports the institute did not meet the requirements specified in the Emergency Use Authorization (EUA) for the Battelle Critical Care Decontamination System. Under the EUA, the Decontamination System is authorized for use in decontaminating certain N95 respirators for reuse by health care workers in the event of insufficient supplies due to the pandemic.

This is the second the FDA has sent the institute, the first being in August requesting information about their process for submitting reportable adverse events to the FDA.

“It is critical that manufacturers have an effective process in place for reporting adverse events related to the use of authorized systems for decontaminating respirators,” said Binita Ashar, M.D., director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health. “When there is an inadequate adverse event reporting process, the ability to detect problems and address them in order to assure the safety and performance of decontaminated respirators is compromised.”

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