On September 23, 2020, mdi Consultants successfully obtained EUA authorization for our client Jiangsu Well Biotech Co., Ltd.’s “Orawell IgM/IgG Rapid Test”.
This is only the 16th rapid antibody test authorized by the FDA to identify the presence of both IgG and IgM antibodies since the EUA period began in March, 2020. Throughout the FDA review process, the FDA continued to tighten the requirements for these tests, especially for tests being manufactured outside of the country (ie. China). The FDA even added the requirement of having additional independent validation testing in conjunction with the NIH. mdi has been working with several companies throughout this year to pursue authorization for diagnostic tests ranging from antibody tests to antigen and PCR tests.
mdi has been working closely with the FDA reviewers and trying to keep on top of the changing requirements for the validation testing, to assist our clients in making sure their applications can pass through the FDA review as rapidly as possible.
If your company would like to utilize mdi Consultants to assist with obtaining EUA authorization for a COVID-19 related diagnostic test, please reach out to firstname.lastname@example.org RE: COVID Diagnostic Test and specify what type of test you are developing.