FDA Issues Guidance to Speed Up Availability of COVID-19 Diagnostic Tests
Yesterday the FDA issued a guidance document to help laboratories and manufacturers developing diagnostics for the novel coronavirus. The document, “Policy for Diagnostic Tests for Coronavirus Disease -2019 during the Public Health Emergency”, establishes a policy that aims to expedite the availability of tests for COVID-19. Due to the fact that this is a public health emergency, the FDA is implementing the guidance without prior public comment.
The guidance document is available for download immediately. FDA notes that this document supersedes “Policy for Diagnostics Testing in Laboratories Certified to Perform High-Complexity Testing under Clinical Laboratory Improvement Amendments (CLIA) prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency”, which was issued on February 29.
Related Articles
-
The draft guidance proposes updates to clarify how the Breakthrough Devices Program may be applicable to certain medical devices that promote health equity, as well as considerations in designating eligible devices that may benefit populations impacted by disparities in health…
-
The updated guidance document clarifies what constitutes a statement of the basis for the deficiency and includes examples of well-constructed deficiencies and industry responses to facilitate a more efficient review process.
-
The new guidance is intended to establish confidence in automation used for production or quality assurance systems and describe various methods and testing activities that may be applied to establish computer software assurance and meet regulatory software validation requirements.
-
Manufacturers preparing premarket submissions should provide performance specifications for the quantitative imaging functions, supporting performance data, and sufficient information for the end user to obtain, understand and interpret the values provided.
