May 22, 2026, NCHR submitted comments to NIH on their draft of resources needed for investigational implantable device trials, emphasizing the need for better planning to make sure that patients understand the medical and financial risks of having an experimental implant that may be found to be neither safe nor effective. Patients volunteering for clinical trials of implanted devices deserve to know the risks and be protected from long-term device-related risks and medical care.
Read More »On Health Policy
NCHR Written Comment to FDA on the Plausible Mechanism Framework for Developing Individualized Therapies for Genetic Conditions
April 27, 2026: NCHR raises concerns about the FDA’s proposed plausible mechanism framework for therapies targeting rare and genetic diseases, warning that reliance on such very limited evidence makes it difficult or impossible to make informed choices based on safety and effectiveness, and means even more very high costing unproven drugs, which patients will pay for directly or through health insurance.
Read More »NCHR Written Comment on why the Department of Education’s Proposal to Reduce Graduate Student Loans for Nurses and Therapists would worsen shortages in access to health care
March 2, 2026: In response to a request for written comments, NCHR warned the U.S. Department of Education warning that its proposed graduate student loan limits would worsen the shortages of nurses, clinical psychologists, physical therapists, occupational therapists, and clinical social workers. Higher loan levels are needed to reverse national workforce shortages and provide essential healthcare, especially in rural, underserved, and less populated areas of the U.S.
Read More »NCHR Written Comment on Exempting AI and Computer-Assisted Medical Devices from FDA Regulation and Safeguards
February 27, 2026: In response to a request for written comments, NCHR told the FDA why we oppose exemptions from 510(k) premarket review for computer-aided radiology devices. NCHR warns that these tools can influence diagnosis and triage decisions and should undergo rigorous evaluation to ensure safety, effectiveness, and equitable performance in real-world clinical settings.
Read More »NCHR Comment on the Reauthorization of MDUFA
September 4, 2025: NCHR’s written public comment to FDA on MDUFA says user fees should support improvements in safety and effectiveness by paying for salaries for staff to improve premarket review, post-market surveillance and other activities, and inspections of manufacturing facilities. Industry has benefitted from MDUFA’s speedier reviews and more meetings with FDA staff, but what patients and consumers need most is safer and more effective medical devices. We deserve clear information about risks and benefits, and we can’t get that when 96+% of devices are not studied in clinical trials before being sold.
Read More »