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FDA Guide to AI/ML SaMD: Pathways, PCCP, and Evidence
FDA regulates AI and ML in SaMD using existing device pathways plus AI-specific expectations. Key elements include the 2025 PCCP Â final...
Oct 29, 20245 min read
FDA's Software as a Medical Device (SaMD) Explained
As technology continues to transform healthcare, Software as a Medical Device (SaMD) Â has become crucial in diagnostics, treatment, and...
Oct 25, 20245 min read
Beginner’s Guide to FDA Compliance for Medical Devices
FDA regulates medical devices from classification through postmarket monitoring. This beginner’s guide shows how to determine class and...
Oct 22, 20246 min read
How to Respond to an FDA Warning Letter: Step-by-Step Guide
An FDA warning letter is a public notice of significant violations that requires a written response within 15 working days. This...
Oct 17, 20246 min read
How to Choose the Right Predicate Device for Your 510(k) Submission
When it comes to FDA submissions , selecting the right predicate device  for your 510(k) submission  is one of the most critical steps....
Oct 15, 20246 min read
Top 10 FDA Medical Device Regulatory Mistakes and How to Avoid Them
Navigating FDA regulations  can feel like walking through a maze. One wrong turn, and your medical device’s path to market  could face...
Oct 9, 20245 min read
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