NCHR Testimony at 2016 FDA Workshop on Point of Care Devices for Monitoring Warfarin Therapy

March 18, 2016. Point of care PT/INR devices represent an increasingly important part of the healthcare landscape. Transparent and robust design, performance studies, and clear data supporting safety and effectiveness are required to avoid device problems that could have wide-reaching consequences for patients and public health. The only way to gather such data is through a rigorous PMA process.

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NCHR Testimony at 2016 FDA Science Board Meeting on Opioids

March 1, 2016. Opioid abuse is a crisis in the US. We urge the FDA to perform its own independent assessment of the effectiveness of REMS and make this data publicly available. More transparency is needed to enable us all to work together to find more effective solutions to the challenge of opioid abuse.

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NCHR Testimony at 2016 FDA Meeting on the Classification of Urogynecologic Surgical Mesh Instrumentation and Automated, Blood Cell and Plasma Separators

February 26, 2016. There are a number of devices currently on the market that pose safety risks to the public because they were inappropriately designated Class I. The upclassification of the surgical mesh instrumentation from class I to class II as well as the new classification of centrifuge apheresis devices as class II are both moves towards increasing patient safety. The special controls suggested by the FDA should be carefully evaluated to determine if they are adequate to protect patients from undue harm.

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