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# Enforcement Policy on Sterilizers, Disinfectant Devices
- URL: https://www.fdaweb.com/enforcement-policy-on-sterilizers-disinfectant-devices/
- Published: 2020-03-30T12:00:00.000Z
- Updated: 2026-09-14T16:09:19.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146441

FDA has released a [guidance](https://www.fda.gov/media/136533/download?ref=fdaweb.com) on “Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency.” The document says that during the coronavirus outbreak, the agency 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.” For example, FDA’s policy would apply to a manufacturer’s 510(k)-cleared steam sterilizer that is intended for sterilization of medical devices in healthcare settings, and where the manufacturer now would like to include a statement in the labeling that the device is effective in killing SARS-CoV-2 when used in accordance with the validated sterilization processes identified in the labeling. Additionally, FDA will allow such devices without 510(k) clearance to be distributed and used if there is no “undue risk in light of the public health emergency.”