The Insider Knowledge Your Competitors Don't Want You to Have

These aren't generic answers from FDA websites. This is the battle-tested intelligence from 300+ successful submissions—the exact strategies that separate companies who get approved from those who get rejected.

Medical Device Classification

FDA Regulatory Processes

FDA Fees (2022)

General Wellness Products

Don't Let Confusion Cost You 12 Months

The wrong regulatory strategy will torpedo your entire product launch. Get personalized answers from experts who've guided 200+ devices through FDA approval—schedule your free strategy call now.

The Insider Knowledge Your Competitors Don't Want You to Have

Medical Device Classification

Is my product classified as a medical device? What's the official definition according to US FDA?

What are some categories of products that FDA is thinking NOT to regulate as medical devices?

What are the different classifications of medical devices by FDA?

FDA Regulatory Processes

What is a FDA 510(k)?

What is FDA Premarket Approval (PMA)?

How do you protect my Intellectual Property (IP) when applying for approval in China?

How does the "Simultaneous 3-Market" strategy work? Do I need separate testing?

FDA Fees (2022)

What does the 2022 FY US FDA government fee schedule look like?

General Wellness Products

What are General Wellness Products?

Don't Let Confusion Cost You 12 Months