Laboratory-Developed Tests: Why does FDA think they can Regulate them, and why do others think they Cannot - 2017
10 Aug 2017
Webinar
Description
Topics
"Enforcement Discretion" and how it has been applied to LDT regulation
Definition of medical device, (21 USC 321(h))and how it has been interpreted by FDA and the courts
Role of US Congress in answering the question of FDA authority
Extent of CLIA 88 authority over LDT performance
International (EU) approach to LDTs
Who should Attend
Attendees with job titles such as:
Complaint Coordinator
QA Specialist
QA Manager
Regulatory Specialist
QA Trainer
Past Events
Laboratory-Developed Tests: Why does FDA think they can Regulate them, and why do others think they Cannot - 2017 - 10 Aug 2017, Webinar (68850)
Important
Please, check "Laboratory-Developed Tests: Why does FDA think they can Regulate them, and why do others think they Cannot" official website for possible changes, before making any traveling arrangements
Event Categories
Health & Medicine: Medical device, Medical laboratories, Pharma
