The FDA issued its new draft guidance for how it defines a low risk product promoting health management and when that device crosses into the territory of medical devices. The goal is to clarify regulations governing the rapidly growing area of sensors and wearables market on full display at the CES conference this month. It’s particularly interested in clarifying not only products that cross into areas like helping people relax, concentrate and improve self-esteem, but also businesses that are pitching their products for specific conditions.
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