March 28, 2016. Our review of the research indicates that ECT devices should remain as class III and should be subject to PMA review. The risks for patients associated with down classification of ECT devices for depression greatly outweigh any presumed benefit.Read More »
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.Read More »
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.Read More »
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.Read More »
February 25, 2016. The lack of a comparison group or data for substantial groups of women most likely to suffer from fecal incontinence makes it impossible to determine if this device would benefit them. A control group is needed to determine if the device is effective for anyone, and if it is, it should be approved only for the types of women studied, not for the types of women who were intentionally excluded.
We encourage you to recommend that these studies be conducted before a decision is made about whether or not to approve this device.