December 6, 2023: In its public comment, members of the Patient, Consumer, Public Health Coalition urged FDA to institute stronger standards to determine clinically meaningful substantial equivalence for 510(k) clearance.
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Patient, Consumer, and Public Health Coalition Comments Regarding the FDA Draft Guidance Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions
December 6, 2023: In its public comment, members of the Patient, Consumer, Public Health Coalition urged FDA to rely more on scientifically credible types of clinical data for 510(k) to ensure patients’ health and safety.
Read More »Patient, Consumer, and Public Health Coalition Comments to FDA on their Guidance for Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission
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.
Read More »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.
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