Laboratory-Developed Tests - Medical devices 2017
- Start Date:
- Thursday, 10 August, 2017
- End Date:
- Thursday, 10 August, 2017 11:00am
- Health & Nutrition
Overview:This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests.Why should you Attend:This 1 hour session will explore the reasons FDA has for claiming such jurisdiction, and the objections to FDAs' position articulated by the clinical laboratory community, and others.
Areas Covered in the Session:"Enforcement Discretion" and how it has been applied to LDT regulationExtent of CLIA '88 authority over LDT performanceRole of US Congress in answering the question of FDA authorityInternational (EU) approach to LDTsWho Will Benefit:QA SpecialistComplaint CoordinatorRegulatory SpecialistQA ManagerQA TrainerAll above in Medical Device companiesSpeaker Profile:Anna Longwell is currently principal attorney of the Palo Alto Law firm, Longwell and Associates, which specializes in Food and Drug law.
The firm has expertise in US FDA expectations, regulation and law, affecting the development and ultimate marketing of new medical products, drugs, devices and biologics. They have served the regulatory needs of large (>$2 billion/year) divisions of Fortune 500 companies, and small (4 person) biotech start-ups.Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: support@compliance4All.com
161 Mission Falls Lane,
Conference organized by Netzealous LLC DBA - Compliance4All
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
- Netzealous LLC DBA - Compliance4All