Recently, the FDA has questioned partial thromboplastin time (PTT) that has been run on a Cascade M-4 analyzer. The FDA has concerns about the equipment’s accuracy and sensitivity, and has indicated a preference for results from a BFT II analyzer. A backlog of PTT testing has resulted since many labs do not offer BFT II analysis.
Topics: Medical Device, Preclinical Safety, Biological Safety Testing, Regulatory, FDA, biocompatibility, hemocompatibility
Topics: Regulatory, FDA, consultant
We are pleased to announce that Li Yang, Ph.D., DABT, has joined our team as a Senior Scientific Director in WuXi AppTec Laboratory Testing Division’s Medical Device Consulting Group.
Topics: Regulatory, FDA, Scientific Director, consultant
