Food And Drug Administration
The FDA Answers COVID-19 Questions
This section is primarily intended for SARS-CoV-2 test developers. For general public and consumer FAQs on COVID-19, please see FDA’s COVID-19 Frequently Asked Questions.
This section provides answers to frequently asked questions relating to the development and performance of tests for SARS-CoV-2. These questions and answers provide additional clarity on existing policies and do not introduce any new policies or modify any existing policies.
This section includes questions and answers regarding the policies described in the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised), originally issued as Policy for Diagnostic Tests in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency on February 29, 2020 and updated on March 16, 2020, May 4, 2020, May 11, 2020, and November 15, 2021. In this section, this guidance is referred to as the Policy for Coronavirus Disease-2019 Tests.
Tests being offered prior to or without an EUA as described in a policy in a previous version or the current version of the Policy for Coronavirus Disease-2019 Tests have not been reviewed or authorized by the FDA. As stated in the current and previous versions of the Policy for Coronavirus Disease-2019 Tests, all such tests should be validated by the developer prior to being offered for clinical use.
Gloves
Medical gloves are used by health care personnel to prevent the spread of infection or illness. Medical gloves are disposable and include patient examination gloves and surgeon’s gloves.
The FDA continues to take a number of steps to find and stop those selling unsafe and unapproved products by investigating, examining and reviewing medical products, both at ports of entry and within domestic commerce, to help ensure the safety of our national supply chain.
To help expand the availability of medical gloves during the COVID-19 public health emergency, the FDA is providing regulatory flexibility under certain circumstances intended to prevent the devices from presenting an undue risk, as described in the enforcement policy for gloves during the COVID-19 public health emergency. The FDA is also providing regular updates about medical gloves, including the answers to frequently asked questions on this page.
More Topics
Hand Sanitizer and COVID-19
Medical glove FAQ’s
Surgical masks and gown shortages FAQ’s
And many more here: Link