December 6, 2023: In its public comment, members of the Patient, Consumer, Public Health Coalition told FDA that if a predicate device for 510(k) review does not align with the best practices identified in the FDA guidance, the device should be submitted to De novo or PMA instead.
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NCHR Comments on Consumer Product Safety Commission Scientific Integrity Policy
December 4, 2023: NCHR urged CPSC to strengthen protections for scientists against retaliation and instill consequences for violations of the scientific integrity policy.
Read More »Patient, Consumer, and Public Health Coalition Comments on the FDA Proposed Rule Regarding Laboratory Developed Tests
December 4, 2023: The PCPH Coalition supported the FDA proposed rule on lab-developed tests (LDTs) to diagnose diseases and genetic issues, with the exception of FDA’s proposed increased use of third-party reviewers.
Read More »Patient, Consumer, and Public Health Coalition Letter to FDA Regarding Consumer Representatives in Advisory Committees
November 20, 2023: The Coalition expressed concerns that patients, health professionals, and industry-affiliated individuals are erroneously categorized as Consumer Representatives on FDA Advisory Committees.
Read More »NCHR Comments on Health and Human Services’ Proposed Healthy People 2030 Objectives
November, 2023, NCHR supports HHS’ proposed healthy people 2030 objectives and the inclusion of social determinants of health as key measurable objectives. To strengthen HHS’ goal of improving community health and achieving health equity, we recommended including individual and organizational health literacy objectives and forming inclusive, diverse stakeholder committees.
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