September 10, 2021. We find the evidence that would support changing the National Coverage Determination inadequate and therefore strongly support maintaining the current non-coverage National Coverage Determination for TPE, and oppose reversing that decision.
Read More »We’re Speaking Out on Health Issues
NCHR scientists and health policy experts provide written and oral statements on a wide range of topics.
Here are many of the ways we have been Speaking Out on Health Policy Issues for the last few years. Whether the topic is legislation intended to cure diseases, proposed bans on BPA or other chemicals that disrupt your hormones, the importance of including women, people of color, and patients over 65 in clinical trials, or many other topics, you’ll gain a better understanding of our evidence-based analyses by reading these letters, statements, and testimony.
Here are the ways we have been Speaking out on Medical Treatments and Products, such as prescription drugs and medical devices that the FDA is considering approving, or is considering taking off the market because of serious risks. Whether the topic is Chantix, Addyi, Yaz, Essure, or medical products you’ve never heard of, you can find out more about what is known and not known about the safety and effectiveness of a wide range of products by looking through this section of our website.
NCHR’s Comments on Conveying Materials Information About Medical Devices to Patients
August 18, 2021. All information about materials should be listed in an understandable and accessible way for all devices – even tiny ones that are not the major focus of a surgical procedure – so that patients can make informed choices about their medical care.
Read More »NCHR’s Comments on Screenings for Atrial Fibrillation in Asymptomatic Adults
May 17, 2021. We support the “I” rating that there is insufficient evidence to assess the benefits and harms of screening for atrial fibrillation in asymptomatic adults ages 50 and over.
Read More »NCHR’s Comment on Class I Surgeon’s and Patient Examination Gloves
May 17. 2021. We enthusiastically support the proposal to withdraw the January exemption for the Class 1 gloves noted above, returning the requirement for a report under section 510(k) of the FD&C Act.
Read More »NCHR’s Testimony to FDA on the TriGUARD 3 Device
NCHR’s Dr. Meg Seymour testified at an FDA Advisory Committee about why the TriGUARD 3 device is not substantially equivalent to its predicate device, Sentinel. She explained that TriGUARD 3 failed to meet its primary effectiveness endpoint, with patients twice as likely to have a stroke compared to the control group.
Read More »