> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Immediately-in-effect Guidance on Face Masks, Respirators
- URL: https://www.fdaweb.com/immediately-in-effect-guidance-on-face-masks-respirators/
- Published: 2020-03-25T12:00:00.000Z
- Updated: 2026-09-14T16:08:51.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146420

FDA late 3/25 issued an immediately-in-effect guidance: [Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency](https://www.fda.gov/media/136449/download?ref=fdaweb.com). The agency said it “believes the policy set forth in this guidance may help address urgent public health concerns by helping to expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95 respirators) for health care professionals.”

The 13-page nonbinding guidance separates face masks that are intended for a medical purpose and don’t provide liquid barrier protection from those that do, saying that each need not submit a 510(k) prior to marketing throughout the period of the coronavirus public health emergency. The document also provides detailed guidance on FDA’s approach to reprocessing of such devices and says the agency is interested in interacting with manufacturers of masks and respirators that are not legally marketed in the U.S. “to increase supply of these devices.”