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:
All above in Medical Device companies
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.
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