A new report from the California Healthcare Institute shows a positive convergence of performance among FDA’s device review divisions, but the biomedical industry group thinks more policy reforms that build on models from the best performing CDRH divisions and branches might be warranted.
Consistency in the performance of CDRH review divisions has improved in recent years, but FDA and lawmakers should closely monitor uniformity across the center and consider the need for reforms, according to the California Healthcare Institute.
CHI, an advocate for California’s biomedical companies, issued a report with help from The Boston Consulting Group on...
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The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.
