FDA's Current Regulatory Perspectives for IVDs and
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Website https://compliance2go.com/product/?pid=CP2014-398 |
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Category Healthcare , Medical Device , Pharmaceutical
Deadline: December 03, 2014 | Date: December 03, 2014
Venue/Country: Houston, U.S.A
Updated: 2014-11-03 18:32:50 (GMT+9)
Call For Papers - CFP
DESCRIPTIONThe US Food and Drug Administration (FDA) has been exercising enforcement discretion for laboratory developed tests (LDTs). FDA may soon begin to regulate LDTs as FDA is now proposing to regulate LDTs. Clinical/medical laboratories, pathology groups, and specialty molecular and genetic testing labs have some concerns about what will be in the final rules. In addition, in vitro diagnostic device (IVD) industry has some legitimate concerns about FDA’s resources when it begins to regulate the LDTs. When various factors are taken into consideration, stakes are high for those clinical laboratory companies including those with patent-protected or proprietary-LDTs. It becomes of paramount importance more than ever to the affected industry (medical laboratories, pathology groups, and specialty molecular and genetic testing labs) including IVD industry to understand what and how exactly FDA is proposing to regulate the LDTs.This presentation is intended to help affected industry including IVDs get familiar with the FDA’s proposed regulation of LDTs so that the industry can be better prepared for the implementation of the proposed rules when finalized. This presentation will provide great opportunities to get familiar with and plan to achieve compliance and sustainability when FDA begins to regulate LDTs.Please join and have your LDT products in your laboratory under check to be compliant with the FDA’s implementation of the proposed rules when finalized. Areas To Be Covered in this Webinar:Statutes, Regulations and GuidanceDefinitionsMedical Device ClassificationRegulatory Requirements for FDA Clearance or ApprovalLaboratory Developed Tests (LDTs): The Past, Present and FutureLDTs’ ClassificationFDA’s Proposed PlanFDA’s Guidance: What to Know and What to Do!What Should Be Your Actionable Plan AheadHow to Prepare for FDA’s Implementation of Regulating LDTsCommon Misunderstanding and Problems: How to AvoidAchieving Compliance with Sustainability: Dos and Don’tsPASS-IT Recommendations: Best PracticesWho will benefit:Clinical LaboratoriesPathology GroupsSpecialty Molecular Testing LabsSpecialty Genetic Testing LabsRegulatory AffairsQuality ProfessionalsProduct Development ProfessionalsHospital ManagementConsultantsSenior ManagementContractors And SubcontractorsAnyone Interested In The SubjectWebinar Includes:Q/A Session with the Expert to ask your questionPDF print only copy of PowerPoint slides60 Minutes Live Presentation
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