FDA Clears New Indications for Existing Lyme Disease Tests That May Help Streamline Diagnoses

July 31, 2019

Today, the Food and Drug Administration (FDA) announces it has cleared for marketing four previously cleared tests with new indications to aid in the diagnosis of Lyme disease. The tests cleared today are the first time that a test has been indicated to follow a new testing paradigm in which two tests called enzyme immunoassays (EIA) are run concurrently or sequentially, rather than the current two-step process in which a separate protein test called a Western Blot must be run after the initial EIA test.

FDA Issues Statement on Shutdown of Large Contract Sterilization Facility

March 27, 2019

Food and Drug Administration (FDA) commissioner Scott Gottlieb, MD, has issued the following statement on steps the agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contract sterilization facility: