FDA ESTABLISHES A NEW DIGITAL HEALTH ADVISORY COMMITTEE
January 18, 2024
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The world of technology is moving at lighting speed. We are experiencing advances in software
On Jan. 8, 2024, the FDA updated the final guidance on “Submission and Review of
The Medical Device Coordination Group (MDCG), the regulatory body that works toward ensuring the safe
Laboratory developed tests (LDTs) are in vitro diagnostic devices (IVDs) for use in clinical settings
CLASS III FIH TRIAL CHALLENGE:A Class III medical device startup required clinical affairs and submission
IDE STUDY CHALLENGE:A medical device startup required expertise in designing, managing, and executing an investigational
CHALLENGE:A small medical device start-up required support planning, managing, and executing a post-market clinical study
510(K) CLEARANCE CASE STUDY CHALLENGE:The manufacturer of a new laser-resistant endotracheal tube device needed to
REGULATORY STRATEGY CASE STUDY CHALLENGE:A large international medical diagnostic system equipment manufacturer was beginning to
