Question:

Our company is developing a saliva test for SARS-CoV2. We plan to use our data to apply to the FDA for an Emergency Use Authorization. We are asking children undergoing a standard COVID-19 nasal PCR test at school to provide a saliva sample for our validation study. The school nurse collecting the nasal swab for the standard test will obtain permission from the student and parent to collect the saliva sample. No personally identifying information of any kind will be provided to our company. Do we need an IRB review and approval?
– President, Medical Device Company

Response:

Because your research involves the development of an in vitro medical device, FDA’s regulatory requirements for IRB review as well as the requirements for informed consent and additional safeguards for children apply to the research you describe.

We recommend that you consult with FDA early on in the development process if you have not already done so. A good starting point for information about the Emergency Use Authorizations for medical devices during the COVID-19 pandemic is https://www.fda.gov/medical-devices/emergency-situations-medical-devices/coronavirus-covid-19-and-medical-devices#ivd. This website includes links to templates for EUA submissions as well industry hotlines and email contact information for FDA staff who are available to help guide your company through the EUA process.