Posts tagged low risk device.
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FDA published the long awaited draft guidance on wellness products last Friday. The guidance is a positive step forward for industry in that it proposes that certain general wellness products will not be subject to FDA regulation.
The draft guidance clarifies that FDA does not intend to enforce its regulations against products that are "low risk" and are intended to:
- Maintain or encourage health without reference to a disease or condition (e.g. weight, fitness, stress) or
- Help users live well with or reduce risks of chronic conditions, where it is well accepted that a healthy ...
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