NEW YORK, Dec. 8, (GenomeWeb News) - The US Food and Drug Administration released today a draft guidance for industry on the types of information the agency would consider during the premarket review of nucleic acid-based in vitro devices that detect exposure to pathogens.
The draft document, which represents the FDA's current thinking on nucleic acid-based in vitro diagnostic devices, comes at a time when the US government and many companies are actively engaged in developing microarrays and diagnostics tools to detect and manage such pathogenic diseases as bird flu and anthrax.
The FDA acknowledged the recommendations are "purposefully" general as they are intended to be a "framework" for the types of data that should be addressed in the premarket review of these devices.
The 26-page document, which can be found here, outlines its recommendations under four headings: Risks to Health, Device Descriptive Characteristics, Performance, and Labeling.
The section on risks recommends providing sufficient detail to indicate the device has been designed to reduce errors in performance or in interpreting test results. Device characteristics seeks information on the patient population to be tested, targeted disease and organism, testing methods, reagent components, instruments to be used, and safety aspects.
Under performance, the recommendations specify data indicating reliability, diagnostic accuracy, and reproducibility. Finally, labeling requests information on how specimens were collected and the types of collection devices used.
The guidance document is intended to offer the "least burdensome" approach, the FDA said. The agency invites comments and suggestions regarding the recommendations outlined in the draft document within 90 days.