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Episode 84  |  31:52 min

Understanding The Differences Between Clearance vs Approval vs Granted

Episode 84  |  31:52 min  |  11.07.2019

Understanding The Differences Between Clearance vs Approval vs Granted

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This is a podcast episode titled, Understanding The Differences Between Clearance vs Approval vs Granted. The summary for this episode is: Are you confused by regulatory terminology? Clearance. Approval. Granted. Do these terms matter or make a difference when it comes to medical devices and working with the FDA? Yes, they do! Mike Drues of Vascular Sciences joins me to talk about the differences between clearance vs. approval vs. granted, which are the three most common ways medical devices are brought to market. Some of the highlights of the show include: ● Clearance: When a 510(k) is cleared from the FDA. Approval: When a PMA is complete. Granted: When a De Novo is complete by the FDA. ● There are reasons to get angry when medical device companies use incorrect terminology. What other mistakes might they be making? ● Riegel v. Medtronic Case: U.S. Supreme Court held that the level of safety and effectiveness of a PMA medical device is higher than a 510(k). ● There are pros and cons to each pathway. Know all your options because 510(k) is not necessarily the best. ● Companies should not avoid PMAs as a convenient excuse because they think extra time, work, risk, and investment are involved. Instead, pursue them. ● The safety and effectiveness of a medical device is never dependent on whether it is cleared, approved, or granted. So, set the bar high on its worthiness.
Are you confused by regulatory terminology? Clearance. Approval. Granted. Do these terms matter or make a difference when it comes to medical devices and working with the FDA? Yes, they do! Mike Drues of Vascular Sciences joins me to talk about the differences between clearance vs. approval vs. granted, which are the three most common ways medical devices are brought to market. Some of the highlights of the show include: ● Clearance: When a 510(k) is cleared from the FDA. Approval: When a PMA is complete. Granted: When a De Novo is complete by the FDA. ● There are reasons to get angry when medical device companies use incorrect terminology. What other mistakes might they be making? ● Riegel v. Medtronic Case: U.S. Supreme Court held that the level of safety and effectiveness of a PMA medical device is higher than a 510(k). ● There are pros and cons to each pathway. Know all your options because 510(k) is not necessarily the best. ● Companies should not avoid PMAs as a convenient excuse because they think extra time, work, risk, and investment are involved. Instead, pursue them. ● The safety and effectiveness of a medical device is never dependent on whether it is cleared, approved, or granted. So, set the bar high on its worthiness.

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