Test Slide - American Intellectual Property Law Association：测试幻灯片-美国法律协会.pptVIP

FDA Regulation of Diagnostic Tests Jeffrey N. Gibbs Hyman, Phelps McNamara, P.C. Washington, DC jgibbs@ Introduction In Vitro Diagnostics (IVDs) are playing an increasingly important role in medicine. Many new types of diagnostics being developed. Introducing new diagnostics to the market presents potential regulatory challenges. Definition of an IVD A product intended to be used to “diagnose a disease or other condition” is regulated as a device. “Diagnose” has been given a broad interpretation by the courts. “Diagnose” also encompasses screening, monitoring, prognosis, etc. Technology does