Posternak Blankstein & Lund LLP is now Arent Fox. Read the press release

FDA Loosens Requirements for Sterilizers, Disinfectant Devices, and Air Purifiers

Over the past weekend, the FDA issued yet another Final Guidance to relax the rules governing medical devices.

In this new Guidance[1], the FDA says it is expanding “the availability and capability of sterilizers, disinfectant devices, and air purifiers during this public health emergency” because these devices “can facilitate rapid turnaround of sterilized or disinfected medical equipment and help reduce the risk of viral exposure for patients and health care providers to SARS-CoV-2.”
The devices covered by the Guidance are the following:
1.  Sterilizers for use in health care facilities that render medical devices sterile. These products range in size from small table-top sterilizers to large sterilizers intended for large loads and include steam, ethylene oxide, vaporized hydrogen peroxide, and other modalities.

2.  Disinfectant Devices that are intended to kill pathogens and other kinds of microorganisms by chemical or physical means. The types of disinfectant devices used in health care settings include chemical/physical disinfectant devices and ultraviolet (UV) disinfectant devices.
3.  Air Purifiers that are designed to kill pathogens/microorganisms in the air by exposure to UV radiation or remove them by filtration.
FDA first discusses its conclusions that coronaviruses are “RNA viruses enveloped in a lipid bylayer” and, as such, “are the least resistant microorganisms on the scale of descending order of resistance to germicidal chemicals.”[2] Because of this, the Agency believes that during this public health emergency, it can lessen certain requirements covering these three types of devices, and it is doing this by an exercise of its enforcement discretion. 
For previously cleared or approved, or even newly marketed, sterilizers, disinfectant devices, and air purifiers, FDA says that it does not intend to object to these being sold for their virucidal effectiveness against SARS-CoV-2 so long as they meet certain FDA-recognized standards, are “intended to be effective at killing the SARS-CoV-2 virus,” and “do not create an undue risk in light of the public health emergency….” And for such devices, the Agency is also waiving the requirements for submitting a Premarket (510(k)) Notification or a Premarket Approval (PMA) application. It is also waiving the registration and listing and Unique Device Identification requirements for these devices. 
The recommended “FDA-recognized standards” are set forth in the Guidance: for Sterilizers at pages 10-11, for Disinfectant Devices at pages 11-12, and for Air Purifiers at pages 12-13. The Agency also “recommends” labeling (see page 13) that includes, among other things, a “clear description of the available data on the device’s new indications or functions related to SARS-CoV-2” and a “clear distinction delineating FDA-cleared or approved indications from those that are not FDA-cleared or approved.”
FDA cautions that the Guidance does “not apply to sterilizers, disinfectant devices, and air purifiers that are intended to prevent or reduce the risks of hospital acquired infections (HAI) or COVID-19.”
This Guidance represents a big change for the FDA.  But by its terms, it only applies while the national health emergency is in effect.


[1] The new Guidance is entitled “Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” It can be found here.

[2] FDA finds that bacterial spores are most resistant, followed by mycobacteria, nonlipid or small viruses, fungi, vegetative bacteria, and finally lipid or medium-size viruses.  The latter encompasses the coronaviruses.


Continue Reading