ICYMI: The FDA’s final guidance on #MedDevice #RemanufacturingRequirements came out last month. Here is a nice summary of the pertinent details. #MedicalDeviceManufacturing #ImprovingPatientsLives #RegulatoryCompliance #MedicalDeviceGuidance
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From the #clinicaltrial trenches: The curiously ambiguous infeasible #feasibility questionnaire. Only 12 pages and more a registration process than a feasibility questionnaire that was promised by the document title. No study. No recruitment questions. The usual – FDA inspections in the past 5 years (Should be “regulatory”. Whatever). Ask an operational question and then asks, “What equipment is available for studies?” Another one or two operational questions. “What equipment is available for studies?” Three operational questions followed by “What equipment is available for studies?” #drugdevelopment #clinicaloperations #clinicalresearch
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In May 2024, the US FDA announced a final ruling that reclassifies laboratory developed tests as medical devices, transforming the diagnostics sector and broadening the scope of in-vitro diagnostic devices. This pivotal change focuses on improving test quality, which ultimately enhances patient safety and care. Our comprehensive white paper explores the implications of this regulation for laboratories, providing valuable insights and strategies for navigating the new compliance landscape. Don't miss out—get your copy now! ⬇️ #LDTs #laboratories #FDA
FDA laboratory developed tests: Unpacking FDA's final rule
ideagen.com
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In May 2024, the US FDA published a final rule classifying laboratory developed tests as medical devices, reshaping the diagnostic testing landscape and expanding the definition of in-vitro diagnostic devices. This change aims to enhance test quality and in turn, patient safety and care. Our white paper delves into the new responsibilities and challenges this regulation brings for laboratories, offering insights and strategies to ensure compliance and success. Access your copy today ⬇️ #LDTs #laboratories #FDA
FDA laboratory developed tests: Unpacking FDA's final rule
ideagen.com
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In May 2024, the US FDA published a final rule classifying laboratory developed tests as medical devices, reshaping the diagnostic testing landscape and expanding the definition of in-vitro diagnostic devices. This change aims to enhance test quality and in turn, patient safety and care. Our white paper delves into the new responsibilities and challenges this regulation brings for laboratories, offering insights and strategies to ensure compliance and success. Access your copy today ⬇️ #LDTs #laboratories #FDA
FDA laboratory developed tests: Unpacking FDA's final rule
ideagen.com
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In May 2024, the US FDA published a final rule classifying laboratory developed tests as medical devices, reshaping the diagnostic testing landscape and expanding the definition of in-vitro diagnostic devices. This change aims to enhance test quality and in turn, patient safety and care. Our white paper delves into the new responsibilities and challenges this regulation brings for laboratories, offering insights and strategies to ensure compliance and success. Access your copy today ⬇️ #LDTs #laboratories #FDA
FDA laboratory developed tests: Unpacking FDA's final rule
ideagen.com
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In May 2024, the US FDA published a final rule classifying laboratory developed tests as medical devices, reshaping the diagnostic testing landscape and expanding the definition of in-vitro diagnostic devices. This change aims to enhance test quality and in turn, patient safety and care. Our white paper delves into the new responsibilities and challenges this regulation brings for laboratories, offering insights and strategies to ensure compliance and success. Access your copy today ⬇️ #LDTs #laboratories #FDA
FDA laboratory developed tests: Unpacking FDA's final rule
ideagen.com
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In May 2024, the US FDA published a final rule classifying laboratory developed tests as medical devices, reshaping the diagnostic testing landscape and expanding the definition of in-vitro diagnostic devices. This change aims to enhance test quality and in turn, patient safety and care. Our white paper delves into the new responsibilities and challenges this regulation brings for laboratories, offering insights and strategies to ensure compliance and success. Access your copy today ⬇️ #LDTs #laboratories #FDA
FDA laboratory developed tests: Unpacking FDA's final rule
ideagen.com
To view or add a comment, sign in
-
In May 2024, the US FDA published a final rule classifying laboratory developed tests as medical devices, reshaping the diagnostic testing landscape and expanding the definition of in-vitro diagnostic devices. This change aims to enhance test quality and in turn, patient safety and care. Our white paper delves into the new responsibilities and challenges this regulation brings for laboratories, offering insights and strategies to ensure compliance and success. Access your copy today ⬇️ #LDTs #laboratories #FDA
FDA laboratory developed tests: Unpacking FDA's final rule
ideagen.com
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In May 2024, the US FDA published a final rule classifying laboratory developed tests as medical devices, reshaping the diagnostic testing landscape and expanding the definition of in-vitro diagnostic devices. This change aims to enhance test quality and in turn, patient safety and care. Our white paper delves into the new responsibilities and challenges this regulation brings for laboratories, offering insights and strategies to ensure compliance and success. Access your copy today ⬇️ #LDTs #laboratories #FDA
FDA laboratory developed tests: Unpacking FDA's final rule
ideagen.com
To view or add a comment, sign in
-
In May 2024, the US FDA published a final rule classifying laboratory developed tests as medical devices, reshaping the diagnostic testing landscape and expanding the definition of in-vitro diagnostic devices. This change aims to enhance test quality and in turn, patient safety and care. Our white paper delves into the new responsibilities and challenges this regulation brings for laboratories, offering insights and strategies to ensure compliance and success. Access your copy today ⬇️ #LDTs #laboratories #FDA
FDA laboratory developed tests: Unpacking FDA's final rule
ideagen.com
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