How to become an authorized lab to use SalivaDirect
If you represent a high complexity CLIA certified lab within the United States and would like to become authorized, please follow the steps below. We are currently working with Yale and FDA legal teams to draft the conditions of the authorization and to formalize regulatory oversight of the process. As this is the first time that the FDA has issued an EUA like this, please understand that it will take us several days to get the required legal documents approved. Then, we will prioritize authorizing labs planning on testing schools first.
If you meet the requirements, here is what you would need to do:
- Fill out this submission form. This will help us understand if you meet the criteria for participation, and to determine what we’d need to do to help you get set up.
- If you represent a for-profit organization, we may issue a license. The license will be free, but we will want to negotiate how much you charge for the tests. We made this to be inexpensive, and we need those savings to be transferred to your customers.
- If we agree to you becoming a designated lab, we will send you a Letter of Authorization, the Fact Sheet, and the Instructions For Use.
- You will follow the Intended Use in the instructions, and order only the designated products for testing (you’ll have options).
- You will be required to report to us any false positive or false negative findings. If significant problems arise, we will make the required protocol changes.
- We will notify you of any protocol changes (such as newly validated reagents or platforms) in the updated Instructions For Use.
- We may schedule weekly Zoom meetings for you and other groups to provide feedback. This will be to help keep our calendars free and to allow you to interact with other users.
- If you have questions, please email us at email@example.com (not our personal emails).