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What Is an IDE? FDA Investigational Device Exemption Guide 2025
An Investigational Device Exemption (IDE) lets an unapproved or new-use device be used in a U.S. clinical study to collect...
Jun 26, 20256 min read
What Is FDA's Breakthrough Devices Program? Complete 2025 Guide
The FDA Breakthrough Devices Program gives truly novel, life-saving technologies a faster lane through 510(k), De Novo or PMA review. As...
Jun 25, 20256 min read
Top Reasons SaMD 510(k)s Get AI Letters (and How to Fix Them)
Most SaMD 510(k)s hit a first-cycle Additional Information (AI) letter , not a final rejection. The recurring issues: missing...
Jun 24, 20257 min read
FDA De Novo Pathway Explained: The Complete 2025 Guide
The De Novo pathway provides marketing authorization for novel, low–to–moderate-risk devices without a predicate , creating a new...
Jun 23, 20256 min read
Pre-market Approval (PMA) Explained: The Complete 2025 Guide
Premarket Approval (PMA) is FDA’s most rigorous pathway, used for most Class III devices (those that support/sustain life, prevent...
Jun 20, 20259 min read
FDA 510(k) Clearance Explained: How It Works (2025 Guide)
A 510(k) premarket notification is how most moderate-risk devices show substantial equivalence to a legally marketed predicate . If...
Jun 19, 20257 min read
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