COVID-19 and Use of Investigational Devices

Please note that information and guidance can evolve rapidly as part of the COVID-19 pandemic. Please visit the U.S. Food and Drug Administration (FDA) website, and the Medical Device website, for the latest information and contact the MSU HRPP with any questions. 

Developing In Vitro Diagnostic Products to Treat COVID-19

When an investigational new device is being used in a clinical investigation, the FDA requires an application for an Investigational Device Exemption (IDE) and authorization from the FDA unless the investigation is considered to have an approved application for an IDE or is exempt from the IDE requirements. IRB review and approval are required for all clinical investigations of devices.

A clinical investigation of an investigational device involves one or more human subjects to determine the safety or effectiveness of a device. Medical devices include in vitro diagnostic products, including reagents and test kits or an algorithm for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body.

Use of de-identified human samples to develop an in vitro diagnostic test still requires IRB review. The FDA had issued guidance related to enforcement discretion on obtaining informed consent when using de-identified samples. 

See HRPP Manual 7-1, Research Involving Investigational Drugs and Devices for the MSU HRPP requirements.


If an investigator would like to develop a new investigational device for use in a clinical investigation, including a new unapproved use or indication of an already FDA approved device product, contact the MSU HRPP as soon as possible. The MSU HRPP may consider use of a central IRB for these kinds of studies. Visit the Medical Devices and the COVID-19 (Coronavirus) Pandemic website for information.

If an investigator would like to participate in a collaborative clinical investigation being conducted under a master protocol, contact the MSU HRPP. While a central IRB may be used for the study, reliance on a central IRB still requires submission to the MSU HRPP and sign off. Please notify us as soon as possible so we can quickly move forward on the reliance process.


Emergency Use Authorizations

The Emergency Use Authorization (EUA) authority allows the FDA to help strengthen the nation’s public health protections against chemical, biological, radiological and nuclear threats by facilitating the availability and use of medical countermeasures needed during public health emergencies.

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological and nuclear threat agents when there are no adequate, approved, and available alternatives.


FDA Emergency Use Authorizations are updated frequently during the COVID-19 pandemic, so please visit the FDA website for the latest information. 

The FDA issued guidance, Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency, to provide a policy to help accelerate the availability of novel coronavirus (COVID-19) diagnostic tests developed by laboratories and commercial manufacturers during the public health emergency. This guidance describes a policy for laboratories and commercial manufacturers to help accelerate the use of tests they develop in order to achieve more rapid and widespread testing capacity in the United States.

While recent the FDA guidance has been issued on diagnostic tests for the coronavirus, its use is limited to CLIA certified labs and commercial manufacturers.