The New FDA LDT Regulations: Key Changes & Compliance Guide
Автор: Celegence
Загружено: 2025-11-23
Просмотров: 8
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The FDA's final rule on Laboratory Developed Tests (LDTs) went into effect on July 5, implementing a phased approach to regulation. Over the next three years, laboratories must update their Quality Management Systems (QMS) in stages: by May 6, 2025, to include adverse event reporting and complaint file maintenance; by May 6, 2026, to complete registration and device listing, and update QMS for labeling and investigational use; and by May 6, 2027, to incorporate remaining FDA requirements like design controls and CAPAs. Depending on the LDT's risk classification, submissions to the FDA will be required by November 6, 2027, or November 6, 2028.
Celegence's team of regulatory experts can help navigate these new requirements by conducting a gap analysis of your current systems, developing a phased compliance plan, and providing an LDT QMS Kit. We offer support in device classification, label revisions, technical documentation, FDA submissions, and inspections. Let us guide you through the regulatory changes to ensure your lab remains compliant and prepared for the future.
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