FDA released recommendations for sponsors of decontamination and bioburden reduction systems about what information should be included in a pre-Emergency Use Authorization (pre-EUA) and/or EUA request to help facilitate FDA’s efficient review of such request.

Decontamination and bioburden reduction systems play an important role in the ongoing efforts to help address shortages of surgical masks and respirators intended for a medical purpose during COVID-19 or reduce the bioburden of surgical masks and filtering facepiece respirators (including N95 respirators) used as personal protective equipment (PPE) by healthcare personnel (hereinafter, “surgical masks and respirators”) for the duration of the COVID-19 public health emergency.

In addition to outlining recommendations about pre-EUA submissions and EUA requests, includinglabeling, for decontamination and bioburden reduction systems in this guidance and issuing EUAs authorizing the emergency use of decontamination systems, FDA has also communicated conservation strategies that are intended to augment, but not replace, specific controls and procedures developed by healthcare organizations, the Centers for Disease Control and Prevention (CDC), or CDC’s Healthcare Infection Control Practices Advisory Committee (HICPAC) to aid in infection control and prevention.

For more details, please see the guideline from FDA.

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Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:

Contact Meditrial for immediate assistance in Europe or the US.