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{"title"=>"Left to their own devices: Breakdowns in United States medical device premarket review", "type"=>"journal", "authors"=>[{"first_name"=>"Jonas Zajac", "last_name"=>"Hines", "scopus_author_id"=>"26653524500"}, {"first_name"=>"Peter", "last_name"=>"Lurie", "scopus_author_id"=>"7005423199"}, {"first_name"=>"Eunice", "last_name"=>"Yu", "scopus_author_id"=>"35333360100"}, {"first_name"=>"Sidney", "last_name"=>"Wolfe", "scopus_author_id"=>"36851095100"}], "year"=>2010, "source"=>"PLoS Medicine", "identifiers"=>{"pmid"=>"20634922", "sgr"=>"77955016199", "doi"=>"10.1371/journal.pmed.1000280", "scopus"=>"2-s2.0-77955016199", "pui"=>"359258168", "isbn"=>"1549-1676 (Electronic)\\r1549-1277 (Linking)", "issn"=>"15491277"}, "id"=>"793e6187-8ce3-365a-90e4-5ad6949c5a22", "abstract"=>"Using examples from recent FDA regulatory proceedings, Jonas Hines and colleagues critique the medical device premarket review and identify eight weaknesses in the process that should be remedied.", "link"=>"http://www.mendeley.com/research/left-own-devices-breakdowns-united-states-medical-device-premarket-review", "reader_count"=>55, "reader_count_by_academic_status"=>{"Professor > Associate Professor"=>7, "Student > Doctoral Student"=>2, "Researcher"=>14, "Student > Ph. D. Student"=>11, "Student > Postgraduate"=>2, "Other"=>9, "Student > Master"=>2, "Student > Bachelor"=>1, "Lecturer"=>1, "Lecturer > Senior Lecturer"=>1, "Professor"=>5}, "reader_count_by_user_role"=>{"Professor > Associate Professor"=>7, "Student > Doctoral Student"=>2, "Researcher"=>14, "Student > Ph. D. Student"=>11, "Student > Postgraduate"=>2, "Other"=>9, "Student > Master"=>2, "Student > Bachelor"=>1, "Lecturer"=>1, "Lecturer > Senior Lecturer"=>1, "Professor"=>5}, "reader_count_by_subject_area"=>{"Engineering"=>5, "Unspecified"=>1, "Materials Science"=>2, "Medicine and Dentistry"=>28, "Agricultural and Biological Sciences"=>10, "Design"=>1, "Philosophy"=>1, "Pharmacology, Toxicology and Pharmaceutical Science"=>2, "Business, Management and Accounting"=>2, "Social Sciences"=>2, "Immunology and Microbiology"=>1}, "reader_count_by_subdiscipline"=>{"Design"=>{"Design"=>1}, "Engineering"=>{"Engineering"=>5}, "Materials Science"=>{"Materials Science"=>2}, "Medicine and Dentistry"=>{"Medicine and Dentistry"=>28}, "Social Sciences"=>{"Social Sciences"=>2}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>10}, "Business, Management and Accounting"=>{"Business, Management and Accounting"=>2}, "Unspecified"=>{"Unspecified"=>1}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>2}, "Philosophy"=>{"Philosophy"=>1}}, "reader_count_by_country"=>{"United States"=>2, "Switzerland"=>1}, "group_count"=>4}

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Figshare

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• {"files"=>["https://ndownloader.figshare.com/files/840657"], "description"=>"<p><i>Note</i>: Issues listed in circles. Issue 8 does not appear in Figure 1. SE, substantially equivalent. * The 1997 FDAMA exempted most class I devices and a small number of class II devices from 510(k) requirements. € If determined to be not substantially equivalent, the sponsor may submit a PMA application. Alternatively, a sponsor may request evaluation under the <i>de novo</i> pathway (see text). Δ Post-decision scheme not illustrated.</p>", "links"=>[], "tags"=>["premarket"], "article_id"=>511117, "categories"=>["Science Policy", "Computational Biology", "Mathematics", "Medicine", "Information And Computing Sciences", "Biotechnology"], "users"=>["Jonas Zajac Hines", "Peter Lurie", "Eunice Yu", "Sidney Wolfe"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1000280.g001", "stats"=>{"downloads"=>3, "page_views"=>12, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Schematic_representation_of_medical_device_premarket_review_mechanisms_/511117", "title"=>"Schematic representation of medical device premarket review mechanisms.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-02-21 00:35:41"}

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Relative Metric

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F1000Prime