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How to Choose the Right FDA Regulatory Pathway for your Device - Featured Image

How to Choose the Right FDA Regulatory Pathway for your Device

By Nick Tippmann on February 26, 2020
Most medical device professionals and companies are familiar with Premarket Approval (PMA) and 510(k...
How FDA Distinguishes Between Clearance vs. Approval vs. Granted - Featured Image

How FDA Distinguishes Between Clearance vs. Approval vs. Granted

By Tom Rish on November 3, 2019
As a medical device professional, you are well aware of how much time and effort goes into getting y...
How to Make De Novo a Viable Option for your Medical Device - Featured Image

How to Make De Novo a Viable Option for your Medical Device

By Nick Tippmann on May 9, 2019
Is de novo a realistic regulatory pathway? Or, the “kiss of death” for your product? No, to de novo?...
De Novo Pathway: Explaining the Process for Medical Device Companies - Featured Image

De Novo Pathway: Explaining the Process for Medical Device Companies

By Jon Speer on April 14, 2019
The De Novo pathway has been around for more than two decades, but it is still one of the least used...
Competitive Regulatory Strategy vs. Regular Regulatory Strategy - Featured Image

Competitive Regulatory Strategy vs. Regular Regulatory Strategy

By Jon Speer on April 23, 2018
Every medical device developer would like to take the fastest path to market, right?

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