UNMET NEED
Serial medtech founder & CEO, Jeff Smith, interviews entrepreneurs leading the next wave of healthcare innovation. Jeff and guests share their experience building the products, teams, and businesses tackling healthcare’s UNMET NEED.
UNMET NEED
#20 - FDA Regulatory Pathways For Medical Devices
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Jeff Smith
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Season 2
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Episode 20
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How regulatory approval with the FDA proceed when it comes to medical devices? Jeff Smith devotes this whole episode to explain. In a clear and on-point discussion, we get valuable information on the different regulations that cover the different classes of medical devices. Jeff also discusses estimates on how long it takes before a product of a certain class becomes FDA-approved. Most importantly, he explains why investing in pre-market approval (PMA) products makes sense. Stay tuned and learn more!