May 22, 2019. The 510(k) pathway system is flawed, and should be replaced with pathways that require controlled clinical trials for all implanted devices and many other devices as well. Meanwhile, safety can be improved with our recommendations.
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NCHR Comments on CPSC Agenda and Priorities for FY2020/2021
May 1, 2019. CPSC has a key role to play in protecting children and adults from harmful products used in their daily life. CPSC should consider artificial turf and playground surfaces, organohalogen flame retardants, and sport and recreational helmets as priorities for FY2020 and 2021.
Read More »Statement on Behalf of Members of the Patient, Consumer, and Public Health Coalition at the FDA Advisory Committee on Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and Informed Consent
March 26, 2019. NCHR testified at the FDA advisory committee meeting on Breast Implants on improving informed consent procedures for informing patients on risks of BIA-ALCL
Read More »NCHR Comment on Proposed Draft Guidance Relating to Patient Experience Data
March 21, 2019. Patient perspectives and experience are important considerations for medical product development and regulation. Patients, caregivers, and patient and consumer groups can provide a valuable resource for product developers and the FDA. Transparency in how the FDA evaluates and uses proposed draft guidances as well as who and how they are developed will be important if they are to provide meaningful and accurate information about patients.
Read More »NCHR Comment on Management of Cybersecurity in Medical Devices
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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