Effects of the COVID-19 public health emergency on formal meetings and user fee applications for medical devices: questions and answers (revised) : guidance for industry and Food and Drug Administration staff
United States. Department of Health and Human Services. issuing body.
United States. Food and Drug Administration. issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, June 2020
This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. This guidance is being implemented without prior public comment because the Food and Drug Administration (FDA or Agency) has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
