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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 256 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 247 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 236 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 209 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 197 min read
SaMD vs SiMD: Quick Comparison for Medical Devices
SaMD (Software as a Medical Device)  is software with a medical intended use  that works independently of device hardware . SiMD...
Jun 175 min read
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