In vitro diagnostics, or IVDs, have a somewhat unique position among the gamut of products that the Food and Drug Administration (FDA) oversees and regulates on behalf of the U.S. public. IVDs are ...

This article is the third in Microbiologics’ series on Optimal QC in the Clinical Laboratory. Previously, in this series we highlighted the importance of external and third-party quality control ...

Among potential changes is that manufacturers will have to anticipate customers’ intended use of their IVD products. The FDA can expect an earful from groups representing diagnostic makers and ...

FDA May Be Considering More Restrictive Approach with Research Use Only Assays Research use only (RUO) products are ubiquitous in the life science industry. They are widely sold, prominently displayed ...