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Enforcement Policy for Sterilizers, Disinfectant 

Devices, and Air Purifiers During the Coronavirus 

Disease 2019 (COVID-19) Public Health Emergency: 

Guidance for Industry and Food and Drug 

Administration Staff

Center for Devices and Radiological Health (CDRH)

U.S. Food and Drug Administration (FDA)

December 8, 2020
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• Sterilization renders devices free from viable 

microorganisms.

• Disinfection kills most recognized pathogenic 

microorganisms.

• It can be inferred these should generally minimize the 

viability of SARS-CoV-2.

• Air purifiers can be designed to filter out virus-sized 

particles.

• During the declared public health emergency, the 

FDA does not intend to object to limited modifications 

to the indications or functionality of FDA-cleared or 

FDA-approved sterilizers, disinfectant devices, and 

air purifiers pertaining to a device’s virucidal 

effectiveness against SARS-CoV-2.

Enforcement Policy for Sterilizers, Disinfectant Devices, 

and Air Purifiers During the Coronavirus Disease 2019 

(COVID-19) Public Health Emergency

Descending Order of Resistance of 

Microorganisms to Germicidal Chemicals

Most Resistant 

Bacterial Spores

Mycobacteria

Nonlipid or Small Viruses

Fungi

Vegetative Bacteria

Lipid or Medium-Size Viruses

Least Resistant 
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The FDA recommends any 

modifications, including 

changes to the indications 

or functionality, to sterilizers 

and their accessories be 

designed, evaluated, and 

validated in accordance 

with FDA-recognized 

standards including, as 

applicable, those listed in 

the guidance.

Enforcement Policy: Sterilizers

Classification 

Regulation

Device Type Product Code Device 

Classification

21 CFR 872.6730 Endodontic dry heat 

sterilizer

KOK Class III

21 CFR 872.6730 Glass bead sterilizer ECC Class III

21 CFR 880.6100 Ethylene-oxide (EO) 

gas aerator cabinet

FLI Class II

21 CFR 880.6860 Chemical Sterilizer MLR Class II

21 CFR 880.6860 Two or more sterilant 

sterilizer

PJJ Class II

21 CFR 880.6860 EO gas sterilizer FLF Class II

21 CFR 880.6870 Dry heat sterilizer KMH Class II

21 CFR 880.6880 Steam sterilizer FLE Class II

21 CFR 880.6880 Sterilizer automated 

loading system

PEC Class II
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• The FDA recommends any 

modifications to disinfectant 

devices be designed, 

evaluated and validated in 

accordance with FDA- recognized standards 

including, as applicable, those 

listed in the guidance.

• The FDA recommends that 

manufacturers of disinfectant 

devices evaluate whether the 

product meets the level of 

disinfection consistent with its 

intended use and labeling 

when combined with 

typical cleaning/ reprocessing 

practices.

Enforcement Policy: Chemical/Physical Disinfectants

Classification 

Regulation

Device Type Product Code Device 

Classification

21 CFR 876.1500 Cleaning accessories 

for endoscope

FEB Class II

21 CFR 880.6885 Medical devices 

sterilant

MED Class II

21 CFR 880.6992 Medical devices 

disinfectors

MEC Class II

21 CFR 880.6992 Medical devices 

cleaners

MDZ Class II

21 CFR 892.1570 High level disinfection 

reprocessing 

instrument for 

ultrasonic 

transducers, mist

OUJ Class II

21 CFR 892.1570 High level disinfection 

reprocessing 

instrument for 

ultrasonic 

transducers, liquid

PSW Class II
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• The FDA recommends that the 

manufacturer evaluate whether the 

product controls for time, UV radiation 

dose, and intensity of UV dose, and 

validates the cleaning and disinfection 

procedures.

• If the device generates ozone, the 

FDA recommends that the 

manufacturer evaluate whether the 

product is within the maximum 

acceptable level of ozone given in 

21 CFR 801.415.

Enforcement Policy: UV Disinfection Devices

Classification 

Regulation

Device Type Product Code Device 

Classification

21 CFR 

880.6600

Ultraviolet 

(UV) 

radiation 

chamber 

disinfection 

device

OSZ Class II
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The FDA recommends that manufacturers of air purifiers evaluate or perform the following:

Enforcement Policy: Air Purifiers

Classification 

Regulation

Device Type Product Code Device 

Classification

21 CFR 

880.5045

Medical 

recirculation 

air cleaner

FRF Class II

21 CFR 

880.6500

Medical UV 

air purifier

FRA Class II

• Demonstration of a 4 log reduction (through a combination of 

capture or destruction) of claimed particulates.

o Air purifying devices are intended for medical purposes to 

kill pathogens/microorganisms in the air by exposure to 

UV radiation or remove them through filtration.

• If intended for use against bacteria, effectiveness against 

representative gram positive and gram negative species.

• If intended for use related to SARS-CoV-2, effectiveness 

against a representative virus.

• If the device generates ozone, the maximum acceptable level 

of ozone per 21 CFR 801.415.

• If intended for use in areas that have a sterile field or 

controlled air flow, a risk assessment to address turbulent air 

flow and/or potential site contamination.
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• Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 

(COVID-19) Public Health Emergency

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-sterilizersdisinfectant-devices-and-air-purifiers-during-coronavirus-disease

• Submission and Review of Sterility Information in Premarket Notification (510(k)): Submissions for Devices 

Labeled as Sterile:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-sterilityinformation-premarket-notification-510k-submissions-devices-labeled

• Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-medical-deviceshealth-care-settings-validation-methods-and-labeling

• Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level 

Disinfectants - Guidance for Industry and FDA Reviewers:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-and-format-premarketnotification-510k-submissions-liquid-chemical-sterilantshigh-level

Resources
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Questions?

Email: 

CDRH-COVID19-SterilizersDisinfectantsPurifiers@fda.hhs.gov

Slide Presentation, Transcript and Webinar Recording will be available at:

https://www.fda.gov/training/cdrhlearn

Under Heading: Specialty Technical Topics and Sub-heading

Personal Protective Equipment (PPE)

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