FDA Issues and Expands EUA for Respirator Decontamination System

Regulatory NewsRegulatory News
| 30 March 2020 | By Michael Mezher 

In a weekend turnaround, the US Food and Drug Administration (FDA) on Saturday gave emergency approval to the first system for decontaminating respirators to extend their use amid the coronavirus disease (COVID-19) pandemic, before expanding the terms of the authorization on Sunday.
The emergency use authorization (EUA) initially limited the number of respirators that could be decontaminated using the system to 10,000 per day, despite Battelle Memorial Institute’s ’s insistence that the system could decontaminate 80,000 respirators per day.
Following backlash from Ohio Gov. Mike DeWine (R) and a request from Battelle to lift the restrictions, FDA reissued the EUA without a cap on how many respirators the system can process per day. The EUA retains a limit of 20 decontamination cycles per respirator.
Respirators and other personal protective equipment (PPE) are in short supply at many hospitals as global demand for the essential medical supplies skyrockets. While many manufacturers are working to increase their output of the devices, FDA has moved to ease restrictions on many products used in the fight against the virus, including ventilators, diagnostics, respirators, masks, surgical gowns, gloves and remote monitoring devices.
The EUA comes just days after FDA said it was interested in allowing companies to disinfect and reprocess otherwise disposable N95 respirators to stretch the supply of the devices.
Under the terms of the EUA, Battelle must provide health care providers and facilities with instructions for preparing and collecting respirators for decontamination, as well as labeling and instructions for use for the decontamination system.
FDA is also requiring Battelle to establish a process for monitoring personnel using the decontaminated respirators and says the company must submit weekly reports to the agency with any reports of infection or potential infection among users.
The EUA covers compatible N95 and “N95-equivalent” respirators, which FDA must be made from non cellulose-based materials and includes imported respirators covered under a separate EUA.
Sterilizers, Disinfectant Devices and Air Purifiers
In a new guidance, FDA spells out its approach to expanding the availability of sterilizers, disinfectant devices and air purifiers.
Typically, such devices would need to be cleared or approved before marketing, and modifications to already approved or cleared devices would also require authorization.
However, in order to increase the availability and use of devices with potential against SARS-CoV-2, the virus that causes COVID-19, FDA is lifting certain regulatory requirements for devices during the public health emergency.
Specifically, FDA says it will allow “limited modifications to the indications or functionality” of already cleared or approved devices related to their effectiveness against SARS-CoV-2 without requiring a 510(k) or premarket approval application (PMA) supplement.
The agency is also allowing companies to distribute sterilizers, disinfectant devices and air purifiers that have not been approved or cleared “that are intended to be effective at killing the SARS-CoV-2 virus.”
In either case, FDA says companies must comply with performance and labeling elements provided in the guidance.
Battelle EUA, Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers


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