Laboratory-Developed Tests: Why does FDA think they can Regulate them, and why do others think they Cannot - 2017 is a webinar that covers topics such as:
- "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
Laboratory-Developed Tests: Why does FDA think they can Regulate them, and why do others think they Cannot - 2017 is intended for attendees with job titles such as:
- Complaint Coordinator
- QA Specialist
- QA Manager
- Regulatory Specialist
- QA Trainer
