FDA Mulls Standards For Neurodiagnostic Tools
This article was originally published in The Gray Sheet
The noninvasive tests of cognitive functioning hold a great deal of promise, but have not yet been fully validated, experts said at a meeting convened by FDA.
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Despite New De Novo Clearance To Assess Brain Injury, ImPACT Concussion Assays Have Been Used For Years
US FDA granted a de novo clearance for ImPACT Applications's ImPACT and ImPACT pediatric tests to assess a patient's cognitive functions for suspected brain injury on Aug. 22, defining a new class of device, "Computerized Cognitive Assessment Aid For Concussion", but the devices have actually been in widespread use by health care providers on behalf of US parents, sporting teams, and schools since 2006, the company tells Medtech Insight.
Aetion is also working with the US Food and Drug Administration and a number of biopharma companies on projects involving use of real-world evidence.
Increased fines and penalties are on the cards for manufacturing facilities that fail to comply with proposed new requirements.