FDA Regulation of Laboratory Developed Tests (LDTs) Speaker: Casper Uldriks Webinar Code: GCT 300 163 Webinar Date: 16th September 2014 10:00 AM PDT | 01:00 PM EDT Webinar Duration: 60(Minutes) Webinar Description : Clinical practitioners may request that a medical laboratory develop an in vitro diagnostic reagent that is specifically designed for that practitioner or a group of practitioners as part of their medical practice. A designated laboratory may manufacture and provide the in-vitro diagnostic accordingly. Although the laboratory operates as a certified laboratory under the Clinical Laboratory Improvement Act (CLIA), FDA seeks to regulate the production of such laboratory tests. FDA’s regulatory initiative brings professional practices and a cumbersome regulatory program into conflict. The need for such regulation needs substantive explanation. Pathologists and their laboratories face a challenge to decades of their standard of care. Clinical institutions and individual clinicians may face a tidal change in how they conduct their practices. Objectives of the Presentation: You will understand the regulatory concern that FDA has and whether subjecting LDTs to the device Quality System Regulation can make a measurable difference for the safety and effectiveness of in-vitro diagnostics. The arguments on both sides of the issue will be laid out and the impact regulation may have on the quality of care we have today. You will also learn that Medical Device Reporting (MDR) and Reports of Corrections and Removals maybe applied to the use of LDTs. You will begin to identify the types of regulatory obligations that will require you to write and establish reporting criteria for LDTs. Areas Covered: FDA’s regulatory framework Reasons for regulation Reasons for no regulation Regulations that apply Manufacturing – Quality System Regulation Reporting – Medical Device Reporting and Reporting of Corrections and Removals Criteria for implementation Who will benefit: Clinical laboratories Pathology practice groups Medical institutions (hospitals) using LDTs Practitioners using LDTs Healthcare maintenance organizations Medical Device and Diagnostic manufacturers Risk managers for healthcare practices Regulatory affairs managers for manufacturers Cost control consultants for healthcare practices Why you should attend: Over the past few years, FDA has edged closer and closer to regulating in-vitro diagnostic reagents developed in laboratories rather than by a registered manufacturer of in-vitro diagnostic products. Public debate pits the cry for standardized regulatory controls against decades of professional practice by licensed healthcare practitioners. How have you planned for the effect of federal regulation and the availability or lack of availability of in-vitro diagnostic products that support clinical specialties? Is FDA encroaching on your practice of medicine and bringing innovative care to a halt? The issue is more than academic. It bargains against healthcare cost control without a reliable cost benefit assessment. How will you as a pro-FDA stakeholder credibly support regulation and how will clinical laboratories and pathologists prove otherwise? This could be a very expensive issue to ignore for healthcare providers, third party reimburses and clinicians that have built their practice around LDTs. Instructor Profile Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture. For more details please contact us at globalcompliancetrainings or you can reach us at 248-212-0588.
Posted on: Mon, 08 Sep 2014 19:54:14 +0000
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