Author: Russek-Cohen, Estelle; Feldblyum, Tamara; Whitaker, Kathleen B.; Hojvat, Sally
Title: FDA Perspectives on Diagnostic Device Clinical Studies for Respiratory Infections Cord-id: uijwq8gx Document date: 2011_5_1
ID: uijwq8gx
Snippet: 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 simul
Document: 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.
Search related documents:
Co phrase search for related documents- absence presence and low prevalence: 1, 2, 3, 4
- absent present and acute respiratory syndrome: 1, 2, 3, 4
- absent present and low prevalence: 1
- acute respiratory syndrome and adequate performance: 1, 2, 3, 4
- acute respiratory syndrome and low confidence: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15
- acute respiratory syndrome and low prevalence: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72
- acute respiratory syndrome and low prevalence disease: 1, 2, 3, 4, 5, 6, 7, 8
- acute respiratory syndrome and low test sensitivity: 1, 2, 3, 4, 5, 6, 7, 8
Co phrase search for related documents, hyperlinks ordered by date