The in vitro diagnostic is designed to detect whole gene segments for influenza A and B viruses and can characterize viruses as seasonal or nonseasonal.
The proposal establishes procedures and criteria for the de novo classification of medical devices that would clarify requirements for submission and review.
The US Food and Drug Administration is developing a new approach for clearing medical devices to take technological advances and modern safety and performance requirements into account.
A genetic analysis of salmon scales collected over the course of a century points to a sharp decline in the number of fish returning each year to river in British Columbia, CBC reports.
