March 18, 2019. We support FDA’s efforts to update their approach to address growing concerns about cybersecurity risks in medical devices through the premarket submission process. Software and medical devices have become increasingly interconnected and vulnerable to network-related cybersecurity breaches, which puts patients at risk. We have several concerns and recommendations to improve the updated guidance.
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NCHR Testimony on the Evaluation for High-Risk HPV Detection Devices
March 8, 2019. NCHR testified on March 8th, 2019 at the Microbiology Advisory Committee urging panel members to consider increasing the screening age from 25 to 30.
Read More »NCHR Comments on USPSTF’s on Pancreatic Cancer Screening
March 4, 2019. We support the USPSTF’s draft recommendation against screening for pancreatic cancer in asymptomatic adults because screening asymptomatic adults does not improve patient outcomes and poses its own risks.
Read More »Statement on Behalf of Members of the Patient, Consumer, and Public Health Coalition at the FDA Advisory Committee on Vaginal Mesh
February 12, 2019. NCHR testified at the FDA regarding vaginal mesh and its harm on patients. Mesh went through a lax approval process and was not proven to be safe before use.
Read More »NCHR Testimony at FDA on Esketamine for Treatment Resistant Depression
February 12, 2019. The data from the clinical trials for esketamine nasal spray are encouraging, but there are still important questions concerning its safety and efficacy.
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