December 23, 2019.We appreciate FDA clarifying plans for regulating Clinical Decision Support (CDS) software; however, we have concerns regarding the draft guidance.
Read More »On Health Policy
NCHR Comments on FDA’s Draft Guidance on Post-Market Studies and Clinical Trials
December 20, 2019. Post-market clinical trials and other studies can help inform FDA and the public about the risks and benefits of medical products. However, when they are relied upon to answer questions better addressed prior to approval, or if less effective studies or trials are used, or if studies are delayed and inadequate, they do not provide the intended data that is needed by FDA, patients, and healthcare providers. This adds to the already high cost of medical care.
Read More »NCHR’s Comments on the Safer Technologies Program (STeP) for Medical Devices
November 18, 2019. We therefore respectfully urge the FDA to revise the proposed guidance in ways that ensure that all medical devices undergo more rigorous testing prior to being approved or cleared.
Read More »Dr. Diana Zuckerman’s Statement on FDA’s Draft Guidance on Labeling for Breast Implants
October 23, 2019. The FDA’s draft includes the types of information that we have proposed to the FDA in recent months in our work with patient advocates and plastic surgeons. The devil is in the details, so we look forward to working with the FDA to finalize these materials so that patients can make better informed decisions in the future than most women considering breast implants have been able to make.
Read More »NCHR Letter to Mayor Cohn and Members of the Rye City Council Concerning Artificial Turf and Playgrounds
October 16, 2019. We have been contacted by families in Rye who are concerned about the risks of artificial turf and playgrounds. We agree with them that converting grass fields to artificial turf poses unnecessary dangers to children in your community.
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