Intended Audience: Pathologists, Residents, Clinical Scientists, Pathologist Assistants
Upon completion of this activity, you will be able to:
- discuss the history of laboratory-developed test regulation in the United States.
- identify challenges in adopting manufacturer-centric medical device...
Back to Regulation of Laboratory-Developed Tests: A Clinical Laboratory Perspective
Intended Audience: Pathologists, Residents, Clinical Scientists, Pathologist Assistants
Upon completion of this activity, you will be able to:
- discuss the history of laboratory-developed test regulation in the United States.
- identify challenges in adopting manufacturer-centric medical device regulatory frameworks in clinical laboratory settings.
- examine key principles for the development of future in vitro diagnostics regulatory proposals.