Medical Devices

During the past several years, government enforcement authorities have focused an increasing amount of attention on the marketing activities of medical device companies.  This increased scrutiny has taken the form of investigations through subpoenas and intervention in qui tam lawsuits (lawsuits initiated by a third …

The Washington Legal Foundation (WLF), a public-interest law and policy center, has challenged FDA’s authority to regulate laboratory developed tests (LDTs), as well as FDA’s proposed method of changing its regulations governing analyte specific reagents (ASRs), which are components of LDTs.  LDTs are commonly referred …