Posts tagged FDA regulations

COVID-19 Testing – Understanding Antibody Tests

There is a lot of conversation about testing. Antibody tests, also called serological tests, help detect the presence of antibodies in blood samples. Antibody testing, when done at large scale, can help us understand the true rates of infection, mortality rates and level of immunity in the population on a regional basis. That is why these tests are a very powerful tool to help fight this devastating disease.

A Pathway to Faster FDA Approvals

FDA is expanding the Abbreviated 510(k) Program with a Safety and Performance-based Pathway for certain medical devices.