WuXi AppTec Now Offers Dual Route Subchronic Toxicity Test

Posted by Sarah Steinmetz, Director Study Operations on August 21, 2018

For your medical device study designs and protocols, our scientists build in the most effective in-vivo or in-vitro model to meet the study goals and stay compliant with governing laws, including the Animal Welfare Act (AWA) when applicable.

At an international level, ISO 10993 working groups, including participants from WuXi AppTec, are challenged to find alternatives to existing in-vivo models as well as ways to meet study endpoints in new and creative ways to reduce current requirements. At the same time, these working groups must ensure that any alternative model or reduction in requirements does not impact the scientific outcomes of the study or, at a minimum, demonstrates equivalency.

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Topics: Medical Device, Biological Safety Testing, biocompatibility, Technical Expertise, Regulatory Expertise

WuXi AppTec Attends FDA Workshop “Accreditation Scheme for Conformity Assessment (ASCA) of Medical Devices to FDA-Recognized Standards"

Posted by Yvonne Leonard, Director of Marketing on July 10, 2018

Our technical and regulatory experts actively participated in the workshop and its biocompatibility round table discussion.

The Federal Drug Administration (FDA) continues to focus on an approach to reduce the burden on medical device manufacturers with the goal to expedite time to market without jeopardizing regulatory oversight related to product safety. The agency’s latest program, Accreditation Scheme for Conformity Assessment (ASCA) of Medical Devices to FDA-Recognized Standards, was formed with this objective in mind.

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Topics: Medical Device, Biological Safety Testing, Regulatory, Scientific Director, biocompatibility, Technical Expertise

WuXi AppTec Offers PTT Testing with BFT II Analysis

Posted by Jean Kringstad, Director In Vitro Services on May 22, 2018

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.

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Topics: Medical Device, Preclinical Safety, Biological Safety Testing, Regulatory, FDA, biocompatibility, hemocompatibility