Funding: This study was supported by funding from the Medical Device Initiative from the Pew Charitable\r\nTrusts. DBK is the Lois Green Scholar at the Hebrew SeniorLife Institute for Aging Research and is supported in\r\npart by a career development award from the Harvard Catalyst Clinical and Translational Research Center. DBK\r\nreports serving as a consultant to the US FDA�s Circulatory Systems Advisory Panel. ASK is also supported by a\r\ncareer development award from the Agency for Healthcare Research & Quality (K08HS18465-01), and a Robert\r\nWood Johnson Foundation Investigator Award in Health Policy Research. The funders had no role in the\r\ndecision to publish or preparation of the manuscript.\r\nCompeting Interests: ASK is a member of the Editorial Board of PLOS Medicine. DBK and ASK previously were\r\nawarded a research contract by the US FDA/CDRH to conduct an independent research project (one piece of\r\nwhich was published in PLOS Medicine). DBK reports serving as a consultant to Circulatory Systems Advisory\r\nPanel of the US FDA. DBK and ASK previously published research funded by US FDA on comparative medical\r\ndevice regulation. DBK and ASK are also supported in part by US NIH career development awards. CS is a\r\nmember for the OECD Advisory Panel of Experts in Health Information Infrastructure, 2013-14, without any\r\npayment. YTT has declared that no competing interests exist.\r\nAbbreviations: CA, Competent Authority; EUDAMED, European Databank on Medical Devices; FDA,\r\nUS food and Drug Administration; FSCA, Field Safety Corrective Action; HDE, Humanitarian Device\r\nExemption; MHLW, Japan Ministry of Health, Labor, and Welfare; MHRA, UK Medicine and Healthcare\r\nProducts Regulatory Agency; MOH, China Ministry of Health; NVB, Notified Body; PMA, premarket approval;\r\nPMDA, Japan Pharmaceuticals and Medical Devices Agency; PS, postmarket surveillance; SFDA, China State\r\nFood and Drug Administration; UDI, unique device identifier.
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