Rethinking medical device regulation
نویسندگان
چکیده
منابع مشابه
FDA medical device regulation and informed consent.
New medical devices are subject to a regulatory scheme designed to ensure safety and effectiveness that is administered by the United States Food and Drug Administration (FDA). Gaining approval to market a device for a specific clinical indication may be time-consuming and costly, particularly for one that poses a potentially unreasonable risk of patient injury and represents genuinely new medi...
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Medical devices have made a significant contribution to helping patients enjoy longer lives of higher quality. However, numerous weaknesses in their premarket evaluation and post-market surveillance have sometimes left patients worse off from faulty devices. For example, the Sprint Fidelis implantable cardioverterdefibrillator lead (Medtronic, Minneapolis, Minnesota) was approved by the United ...
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By the spring of 2005, the European Commission hopes to present the first draft of the revisions to the Medical Device Directive to the European Council and Parliament. However, these revisions represent only part of the changing European regulatory scenario. This article discusses a tangible shift in European medical device regulatory policy and some actions that companies can take to understa...
متن کاملFDA Regulation of Medical Devices and Medical Device Reporting
There are three main stakeholders in medical device regulation: people in industry, regulators and practitioners. A medical device report is filed after a device-related adverse event occurs. Studies show that while most medical device reports begin with practitioner observations, people in industry file 97% of reports and practitioners file 3% of reports. The objectives of this article are to ...
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Purpose – The history of cybernetics holds important lessons for how we approach present-day problems in such areas as algorithmic regulation and big data. The purpose of this paper is to position Project Cybersyn as a historical form of algorithmic regulation and use this historical case study as a thought experiment for thinking about ways to improve discussions of algorithmic regulation and ...
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ژورنال
عنوان ژورنال: Journal of the Royal Society of Medicine
سال: 2012
ISSN: 0141-0768,1758-1095
DOI: 10.1258/jrsm.2012.12k030