August 28, 2023: We support the overall goals of the TCET program, but we see an enormous disconnect between the types of evidence that FDA requires for breakthrough devices and the CED standards that CMS requires for coverage.
Read More »Author: Caroline Bradford
NCHR Comments on the Food and Drug Administration In-Home Disposal Systems for Opioid Analgesics
August 28, 2023 The FDA is assessing whether in-home disposal products can reduce opioid nonmedical use and overdose. We recommend user-friendly, accessible in-home disposal systems that rely on deactivation rather than incineration.
Read More »Testimony at the FDA Advisory Committee Meeting on the Recor Paradise Ultrasound Renal Denervation System
August 22 2023, we testified at the FDA Advisory Meeting on the Paradise Ultrasound Renal Denervation (uRDN) System used to treat hypertension, we attested that the hypertensive efficacy of the Paradise uRDN system is insufficient to justify its use as an adjunct therapy for hypertension.
Read More »NCHR Comment on the CMS National Coverage Analysis Evidence Review Proposed Guidance
August 21, 2023: We support the methodological attributes of clinical studies that are described in the NCA guidance. We also strongly agree with CMS’s priorities that emphasize evidence of meaningful health outcomes, particularly morbidity and mortality, since those can be evaluated more objectively.
Read More »NCHR Comments on the CMS Coverage with Evidence Development Proposed Guidance Document
August 21, 2023: We support the refinements to the proposed new criteria regarding the need for proper control groups and blinding in CED studies. However, we have minor suggestions that would strengthen these changes.
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