The FDA’s Anesthesiology and Respiratory Therapy Devices advisory panel met to discuss racial and skin-pigmentation bias in pulse oximeter devices as well as recommendations for the agency.
The US Food and Drug Administration’s anesthesiology and respiratory therapy devices advisory committee agreed that pulse oximeters with decreased accuracy on patients with dark skin is a problem that comes with clinical implications.
Pulse oximeters measure spO2, which is a percentage of oxygenated hemoglobin to deoxygenated hemoglobin.
The US FDA has published a discussion paper as part of an effort to ensure all patients have timely access to safe and effective medical devices. The agency says the paper fits into a larger strategy of promoting health equity and is seeking public comment on the initiative.
The E in ESG: SUDs, reuse, disposables, refurbishing, reprocessed devices? Multiple panelists at the 2024 MedTech Forum addressed the role medtech manufacturers should have in the climate change challenge.
A fiscal 2025 report from the US House Appropriations Committee instructs the FDA to halt implementation of its overhaul of LDT regulation. Members also showed concern about overseas device manufacturing and the availability of over-the-counter diagnostics.
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.
The European Chemicals Agency’s committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) are evaluating sector by sector the proposed REACH restriction on PFAS and more than 5,600 public comments, reaching provisional conclusions on cosmetics at their June meetings. A date has not been set to consider PFAS uses in medical devices, which are numerous, essential, and in many cases devoid of alternatives, industry says.
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.
New draft guidance on clinical trial diversity action plans pushes for disproportionately high enrollment of traditionally underrepresented groups, while also asking companies to tailor global programs to US populations and consider diversity aspects that Congress did not outline.
