STAT April 2, 2019
Health products are increasingly moving from the realm of the medical professional to the consumer. Direct-to-consumer (DTC) versions of teeth alignment kits, genetic tests, hearing aids, heart-rhythm monitors, neurostimulation devices, and mental health tools are already on the market, causing professional organizations of dentists, geneticists, audiologists, cardiologists, neurologists, and psychiatrists to grapple with challenges to their authority and practice.
So far, questions about safe and appropriate marketing and use have reverberated mainly within individual professional domains. We believe that thinking about these products as part of a larger problem can yield valuable insights.
Since 1976, the Food and Drug Administration has acted as a gatekeeper for companies bringing medical devices to the market. Today, however, many companies bypass the FDA...
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