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Here's what subscribers received last week.
FDA released updated guidance on Software as a Medical Device (SaMD). Key changes include streamlined 510(k) pathways for AI/ML-based devices and new cybersecurity requirements...
We've published a visual flowchart for De Novo classification requests. Download the PDF and share with your team...
When preparing for Pre-Sub meetings, include specific questions rather than open-ended requests. FDA responds better to targeted inquiries...
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