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Laboratory-Developed Tests - Medical devices 2017

Event Details

Laboratory-Developed Tests - Medical devices 2017

Time: August 10, 2017 from 10am to 11am
Location: Online
Street: 161 Mission Falls Lane, Suite 216
City/Town: Fremont
Website or Map: http://www.compliance4all.com…
Phone: Event Manager
Event Type: webinar
Organized By: Adam Fleming
Latest Activity: Jun 22, 2017

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Event Description

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 regulation
Extent of CLIA '88 authority over LDT performance
Role of US Congress in answering the question of FDA authority
International (EU) approach to LDTs

Who Will Benefit:
QA Specialist
Complaint Coordinator
Regulatory Specialist
QA Manager
QA Trainer
All above in Medical Device companies

Speaker 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: +1-800-447-9407
Email: support@compliance4All.com

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