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Episode 48  |  32:25 min

Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission

Episode 48  |  32:25 min  |  11.07.2019

Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission

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This is a podcast episode titled, Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission. The summary for this episode is: It can be confusing to know which submission type is the correct one for your particular development situation. Today we’re going to talk to Mike Drues, president of Vascular Sciences and regulatory guru, about what to keep in mind as you decide whether to use the 510(k), De Novo, 513(g), or Pre-Sub process. Some of the highlights of the show include: ● The difference between the 510(k) and the De Novo submissions and how to decide between them. ● An explanation of why the 510(k) submission process does not include proof of product safety or efficacy. ● Why the number of De Novo submissions is so small and what the process entails in terms of proving safety, as well as how it compares to the pre-market approval (PMA) process. ● How the relationship between a medical device company and the FDA resembles a poker game. ● Some statistics on the 510(k) and the PMA: How many are rejected the first time they’re submitted and why. ● When you should do a 513(g) vs. a pre-sub: how the two processes differ and when you should use each.
It can be confusing to know which submission type is the correct one for your particular development situation. Today we’re going to talk to Mike Drues, president of Vascular Sciences and regulatory guru, about what to keep in mind as you decide whether to use the 510(k), De Novo, 513(g), or Pre-Sub process. Some of the highlights of the show include: ● The difference between the 510(k) and the De Novo submissions and how to decide between them. ● An explanation of why the 510(k) submission process does not include proof of product safety or efficacy. ● Why the number of De Novo submissions is so small and what the process entails in terms of proving safety, as well as how it compares to the pre-market approval (PMA) process. ● How the relationship between a medical device company and the FDA resembles a poker game. ● Some statistics on the 510(k) and the PMA: How many are rejected the first time they’re submitted and why. ● When you should do a 513(g) vs. a pre-sub: how the two processes differ and when you should use each.

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