Federal Register: Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi; Guidance for Industry and Food and Drug Administration Staff; Availability

The FDA is announcing the availability of the guidance entitled "Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi.' FDA is issuing this guidance to provide industry and...
Source: Food and Drug Adminstration (FDA): CDRHNew - Category: Medical Equipment Source Type: news