Today (March 20), the U.S. Food and Drug Administration (FDA) issued an immediately in effect guidance that allows manufacturers of certain FDA-cleared non-invasive, vital-sign-measuring devices to expand their use so that healthcare providers can use them to monitor patients remotely.
The devices include those that measure body temperature, respiratory rate, heart rate, and blood pressure. This policy reflects FDA’s commitment to ease burdens on healthcare providers and facilities as they face COVID-19.
This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the Secretary in accordance with section 319(a)(2) of the Public Health Service Act.
Given this public health emergency, this guidance is being implemented without prior public comment because the FDA has determined such action is not feasible or appropriate (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act [FD&C Act] and 21 CFR 10.115(g)(2) of the Code of Federal Regulations). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the agency’s good guidance practices.
Edited by Gary Cramer