Journal Article

FDA Perspectives on Diagnostic Device Clinical Studies for Respiratory Infections

Estelle Russek-Cohen, Tamara Feldblyum, Kathleen B. Whitaker and Sally Hojvat

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 52, issue suppl_4, pages S305-S311
Published in print May 2011 | ISSN: 1058-4838
Published online May 2011 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1093/cid/cir056
FDA Perspectives on Diagnostic Device Clinical Studies for Respiratory Infections

More Like This

Show all results sharing these subjects:

  • Infectious Diseases
  • Immunology
  • Public Health and Epidemiology
  • Microbiology

GO

Show Summary Details

Preview

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.

Journal Article.  4850 words. 

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

Full text: subscription required

How to subscribe Recommend to my Librarian

Users without a subscription are not able to see the full content. Please, subscribe or login to access all content.