title: FDA perspectives on diagnostic device clinical studies for respiratory infections.
abstract: Two pathways are described for submission to FDA for clearance of a diagnostic device: a Premarket Application (PMA), which can lead to approval of a diagnostic device, and a Premarket Notification, which can lead to clearance. The latter is often called a 510(k), named for the statute providing for this path. Recent FDA clearance of molecular-based multiplex panels represents the beginning of a new era for the diagnosis of respiratory infections. The ability to test for multiple pathogens simultaneously, accompanied by the increasing availability of molecular-based assays for newly recognized respiratory pathogens will likely have a major impact on patient care, drug development, and public health epidemiology. We provide a general overview of how FDA evaluates new diagnostics for respiratory tract infections and the agency's expectations for sponsors developing new tests in this area.
authors: Division of Biostatistics, Office of Biostatistics and Epidemiology, Center for Biologics, Evaluation, and Research, Rockville, Maryland 20852, USA. estelle.russek-cohen@fda.hhs.gov
authors: Estelle
authors: E
authors: Russek-Cohen
authors: Tamara
authors: T
authors: Feldblyum
authors: Kathleen B
authors: KB
authors: Whitaker
authors: Sally
authors: S
authors: Hojvat
mesh_terms: D057069:Diagnostic Test Approval; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D011933:Reagent Kits, Diagnostic; D012141:Respiratory Tract Infections / Q000175:diagnosis*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D011933:Reagent Kits, Diagnostic