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Assessing Respiratory Immune Responses to Haemophilus Influenzae
Published on: June 29, 2021
FDA perspectives on diagnostic device clinical studies for respiratory infections
Estelle Russek-Cohen1, Tamara Feldblyum, Kathleen B Whitaker
1Division of Biostatistics, Office of Biostatistics and Epidemiology, Center for Biologics, Evaluation, and Research, Rockville, Maryland 20852, USA. estelle.russek-cohen@fda.hhs.gov
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.
Insights
The FDA is clearing new molecular diagnostic tests for respiratory infections, enabling simultaneous pathogen detection. This advancement marks a new era in diagnosing and managing respiratory illnesses.
Area of Science:
- Medical Diagnostics
- Infectious Disease Research
- Regulatory Science
Background:
- The U.S. Food and Drug Administration (FDA) regulates diagnostic devices through pathways like Premarket Application (PMA) and Premarket Notification (510(k)).
- Molecular-based multiplex panels are emerging as powerful tools for diagnosing respiratory infections.
Purpose of the Study:
- To provide an overview of FDA's evaluation process for new respiratory infection diagnostics.
- To outline FDA's expectations for developers of novel respiratory diagnostic tests.
Main Methods:
- Review of FDA regulatory pathways for diagnostic devices (PMA and 510(k)).
- Analysis of the impact of molecular-based multiplex panels on respiratory infection diagnosis.
Main Results:
- Recent FDA clearances of molecular multiplex panels signify a significant advancement in respiratory diagnostics.
- Simultaneous detection of multiple pathogens offers improved patient care and public health insights.
Conclusions:
- Molecular multiplex diagnostics are poised to transform the diagnosis and management of respiratory infections.
- Understanding FDA's regulatory expectations is crucial for sponsors developing these innovative tests.
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