Left to Their Own Devices: Breakdowns in United States Medical Device Premarket Review
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Scopus | Further Information

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/840877"], "description"=>"a<p>Although these weaknesses are susceptible to shifts in agency discretionary practices, such changes are not sufficient; for consistent and meaningful improvement, these laws and regulations must be revisited and strengthened.</p>", "links"=>[], "tags"=>["statutory", "corrective"], "article_id"=>511336, "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.t001", "stats"=>{"downloads"=>1, "page_views"=>6, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Summary_of_statutory_and_regulatory_issues_case_exemplars_and_necessary_corrective_actions_/511336", "title"=>"Summary of statutory and regulatory issues, case exemplars, and necessary corrective actions.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-02-21 00:36:54"}
  • {"files"=>["https://ndownloader.figshare.com/files/840757"], "description"=>"<p><i>Note</i>: if a device was later determined to have more than one indication, the review was considered complete only after all indications had been reviewed.</p>", "links"=>[], "tags"=>["iii", "types", "reviewed"], "article_id"=>511218, "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.g002", "stats"=>{"downloads"=>0, "page_views"=>3, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Class_III_510_k_device_types_not_fully_reviewed_by_the_FDA_1976_8211_2009_/511218", "title"=>"Class III 510(k) device types not fully reviewed by the FDA, 1976–2009.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-02-21 00:36:17"}
  • {"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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  • {"unique-ip"=>"12", "full-text"=>"14", "pdf"=>"4", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"3", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2017", "month"=>"12"}
  • {"unique-ip"=>"11", "full-text"=>"10", "pdf"=>"1", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"1", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2018", "month"=>"1"}
  • {"unique-ip"=>"2", "full-text"=>"2", "pdf"=>"0", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2018", "month"=>"2"}
  • {"unique-ip"=>"30", "full-text"=>"33", "pdf"=>"13", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"3", "supp-data"=>"0", "cited-by"=>"2", "year"=>"2018", "month"=>"3"}

Relative Metric

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