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[57] FDA explains that the MAUDE database is a passive surveillance system, and that incidence, prevalence, or cause of an event cannot be determined from this surveillance system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use

Support continues via messaging, and medication is aligned to coverage or flat-rate plan

There is limited human data available, and its safety during pregnancy is not fully established

With the right tools, strategies, and understanding, you can help your child meet their sensory needs safely and successfully