Peter J. Pitts is President of the Center for Medicine in the Public Interest and a Visiting Professor at the University of Paris School of Medicine. He is a former Associate Commissioner of the US Food and Drug Administration and member of the United States Senior Executive Service.
How can physicians and patients be confident enough that vendors entirely ignorant of the FDA process for repair and reporting can properly recalibrate life-saving machines? Is this really the right place to argue that “anyone can do it?”
Policymakers should recognize the advantages of this multi-faceted care model and ensure legislative and regulatory environments allow for its continued growth.
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Healthcare devices must be exempted from general right to repair legislation.