Laboratory developed test (LDT) providers, previously exempt from U.S. Food and Drug Administration (FDA) oversight, under a new FDA proposal, must now consider if their LDTs constitute moderate-risk (Class II) or high-risk...more
10/29/2015
/ 510(k) RTA ,
CLIA ,
Clinical Laboratories ,
Diagnostic Tests ,
Due Diligence ,
Duty of Candor ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Intellectual Property Protection ,
Laboratory Developed Tests ,
Lack of Novelty ,
Medical Devices ,
New Guidance ,
Obviousness ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Personalized Medicine ,
Premarket Approval Applications ,
Proposed Regulation ,
Risk Mitigation ,
USPTO