31 min listen
Understanding The Differences Between Clearance vs Approval vs Granted
FromGlobal Medical Device Podcast powered by Greenlight Guru
Understanding The Differences Between Clearance vs Approval vs Granted
FromGlobal Medical Device Podcast powered by Greenlight Guru
ratings:
Length:
32 minutes
Released:
Nov 7, 2019
Format:
Podcast episode
Description
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.
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.
Released:
Nov 7, 2019
Format:
Podcast episode
Titles in the series (100)
How to Properly Use the FDA Pre-Submission Process and Why It's So Important with Mike Drues: In order to get your medical device to market, you will need to know about pre-submission and the pre-submission process. The FDA is trying to get the safest medical devices out there. The most common reasons that the FDA makes rejections is within t... by Global Medical Device Podcast powered by Greenlight Guru