{"id":"https://openalex.org/W3215095692","doi":"https://doi.org/10.1056/nejmp2117295","title":"A Divisive Ruling on Devices \u2014 Genus Medical Technologies v. FDA","display_name":"A Divisive Ruling on Devices \u2014 Genus Medical Technologies v. FDA","publication_year":2021,"publication_date":"2021-11-24","ids":{"openalex":"https://openalex.org/W3215095692","doi":"https://doi.org/10.1056/nejmp2117295","mag":"3215095692","pmid":"https://pubmed.ncbi.nlm.nih.gov/34818475"},"language":"en","primary_location":{"id":"doi:10.1056/nejmp2117295","doi":"https://doi.org/10.1056/nejmp2117295","is_oa":false,"landing_page_url":"https://doi.org/10.1056/nejmp2117295","pdf_url":null,"source":{"id":"https://openalex.org/S62468778","display_name":"New England Journal of Medicine","issn_l":"0028-4793","issn":["0028-4793","0096-6762","1533-4406","2331-4710"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-class-a","anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320239","host_organization_name":"Massachusetts Medical Society","host_organization_lineage":["https://openalex.org/P4310320239"],"host_organization_lineage_names":["Massachusetts Medical Society"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"New England Journal of Medicine","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5000530257","display_name":"Patricia J. Zettler","orcid":"https://orcid.org/0000-0001-9114-0735","observed_orcids":["https://orcid.org/0000-0001-9114-0735"]},"institutions":[{"id":"https://openalex.org/I136199984","display_name":"Harvard University","ror":"https://ror.org/03vek6s52","country_code":"US","type":"education","lineage":["https://openalex.org/I136199984"]},{"id":"https://openalex.org/I27804330","display_name":"Brown University","ror":"https://ror.org/05gq02987","country_code":"US","type":"education","lineage":["https://openalex.org/I27804330"]},{"id":"https://openalex.org/I2799885155","display_name":"The Ohio State University Comprehensive Cancer Center \u2013 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute","ror":"https://ror.org/028t46f04","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I2799885155","https://openalex.org/I2802841970"]},{"id":"https://openalex.org/I52357470","display_name":"The Ohio State University","ror":"https://ror.org/00rs6vg23","country_code":"US","type":"education","lineage":["https://openalex.org/I52357470"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Patricia J. Zettler","raw_affiliation_strings":["From Moritz College of Law, the Drug Enforcement and Policy Center, and the James Comprehensive Cancer Center \u2014 all at Ohio State University, Columbus (P.J.Z.); the Department of Medical Science, Brown University, Providence, RI (E.Y.A.); and Harvard Law School and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University \u2014 both in Cambridge, MA (I.G.C.)","James Comprehensive Cancer Center \u2014 all at Ohio State University, Columbus"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"From Moritz College of Law, the Drug Enforcement and Policy Center, and the James Comprehensive Cancer Center \u2014 all at Ohio State University, Columbus (P.J.Z.); the Department of Medical Science, Brown University, Providence, RI (E.Y.A.); and Harvard Law School and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University \u2014 both in Cambridge, MA (I.G.C.)","institution_ids":["https://openalex.org/I136199984","https://openalex.org/I27804330","https://openalex.org/I52357470"]},{"raw_affiliation_string":"James Comprehensive Cancer Center \u2014 all at Ohio State University, Columbus","institution_ids":["https://openalex.org/I2799885155","https://openalex.org/I52357470"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5086044543","display_name":"Eli Y. Adashi","orcid":"https://orcid.org/0000-0001-7730-1192","observed_orcids":["https://orcid.org/0000-0001-7730-1192"]},"institutions":[{"id":"https://openalex.org/I136199984","display_name":"Harvard University","ror":"https://ror.org/03vek6s52","country_code":"US","type":"education","lineage":["https://openalex.org/I136199984"]},{"id":"https://openalex.org/I27804330","display_name":"Brown University","ror":"https://ror.org/05gq02987","country_code":"US","type":"education","lineage":["https://openalex.org/I27804330"]},{"id":"https://openalex.org/I52357470","display_name":"The Ohio State University","ror":"https://ror.org/00rs6vg23","country_code":"US","type":"education","lineage":["https://openalex.org/I52357470"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Eli Y. Adashi","raw_affiliation_strings":["From Moritz College of Law, the Drug Enforcement and Policy Center, and the James Comprehensive Cancer Center \u2014 all at Ohio State University, Columbus (P.J.Z.); the Department of Medical Science, Brown University, Providence, RI (E.Y.A.); and Harvard Law School and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University \u2014 both in Cambridge, MA (I.G.C.)","Department of Medical Science, Brown University, Providence, RI"],"raw_orcid":"https://orcid.org/0000-0001-7730-1192","affiliations":[{"raw_affiliation_string":"From Moritz College of Law, the Drug Enforcement and Policy Center, and the James Comprehensive Cancer Center \u2014 all at Ohio State University, Columbus (P.J.Z.); the Department of Medical Science, Brown University, Providence, RI (E.Y.A.); and Harvard Law School and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University \u2014 both in Cambridge, MA (I.G.C.)","institution_ids":["https://openalex.org/I136199984","https://openalex.org/I27804330","https://openalex.org/I52357470"]},{"raw_affiliation_string":"Department of Medical Science, Brown University, Providence, RI","institution_ids":["https://openalex.org/I27804330"]}]},{"author_position":"last","author":{"id":null,"display_name":"I. Glenn Cohen","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I136199984","display_name":"Harvard University","ror":"https://ror.org/03vek6s52","country_code":"US","type":"education","lineage":["https://openalex.org/I136199984"]},{"id":"https://openalex.org/I27804330","display_name":"Brown University","ror":"https://ror.org/05gq02987","country_code":"US","type":"education","lineage":["https://openalex.org/I27804330"]},{"id":"https://openalex.org/I52357470","display_name":"The Ohio State University","ror":"https://ror.org/00rs6vg23","country_code":"US","type":"education","lineage":["https://openalex.org/I52357470"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"I. Glenn Cohen","raw_affiliation_strings":["From Moritz College of Law, the Drug Enforcement and Policy Center, and the James Comprehensive Cancer Center \u2014 all at Ohio State University, Columbus (P.J.Z.); the Department of Medical Science, Brown University, Providence, RI (E.Y.A.); and Harvard Law School and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University \u2014 both in Cambridge, MA (I.G.C.)","Harvard Law School and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University \u2014 both in Cambridge, MA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"From Moritz College of Law, the Drug Enforcement and Policy Center, and the James Comprehensive Cancer Center \u2014 all at Ohio State University, Columbus (P.J.Z.); the Department of Medical Science, Brown University, Providence, RI (E.Y.A.); and Harvard Law School and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University \u2014 both in Cambridge, MA (I.G.C.)","institution_ids":["https://openalex.org/I136199984","https://openalex.org/I27804330","https://openalex.org/I52357470"]},{"raw_affiliation_string":"Harvard Law School and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University \u2014 both in Cambridge, MA","institution_ids":["https://openalex.org/I136199984"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":4,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":{"value":0.25701473,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":"385","issue":"26","first_page":"2409","last_page":"2411"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T14396","display_name":"Healthcare Regulation","score":0.989300012588501,"subfield":{"id":"https://openalex.org/subfields/3605","display_name":"Health Information Management"},"field":{"id":"https://openalex.org/fields/36","display_name":"Health Professions"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T14396","display_name":"Healthcare Regulation","score":0.989300012588501,"subfield":{"id":"https://openalex.org/subfields/3605","display_name":"Health Information Management"},"field":{"id":"https://openalex.org/fields/36","display_name":"Health Professions"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11662","display_name":"Legal Cases and Commentary","score":0.0027000000700354576,"subfield":{"id":"https://openalex.org/subfields/2743","display_name":"Reproductive Medicine"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T13417","display_name":"Biomedical Ethics and Regulation","score":0.002199999988079071,"subfield":{"id":"https://openalex.org/subfields/2737","display_name":"Physiology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/medical-device-regulation","display_name":"medical device regulation","score":0.8119999766349792},{"id":"https://openalex.org/keywords/regulatory-jurisdiction","display_name":"regulatory jurisdiction","score":0.33500000834465027},{"id":"https://openalex.org/keywords/judicial-decisions","display_name":"judicial decisions","score":0.3269999921321869}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.7764902114868164}],"mesh":[{"descriptor_ui":"D001466","descriptor_name":"Barium Sulfate","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D003287","descriptor_name":"Contrast Media","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014481","descriptor_name":"United States","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014486","descriptor_name":"United States Food and Drug Administration","qualifier_ui":"Q000331","qualifier_name":"legislation & jurisprudence","is_major_topic":true},{"descriptor_ui":"D017277","descriptor_name":"Drug Approval","qualifier_ui":"Q000331","qualifier_name":"legislation & jurisprudence","is_major_topic":false},{"descriptor_ui":"D018795","descriptor_name":"Device Approval","qualifier_ui":"Q000331","qualifier_name":"legislation & jurisprudence","is_major_topic":true},{"descriptor_ui":"D033161","descriptor_name":"Government Regulation","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true}],"locations_count":2,"locations":[{"id":"doi:10.1056/nejmp2117295","doi":"https://doi.org/10.1056/nejmp2117295","is_oa":false,"landing_page_url":"https://doi.org/10.1056/nejmp2117295","pdf_url":null,"source":{"id":"https://openalex.org/S62468778","display_name":"New England Journal of Medicine","issn_l":"0028-4793","issn":["0028-4793","0096-6762","1533-4406","2331-4710"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-class-a","anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320239","host_organization_name":"Massachusetts Medical Society","host_organization_lineage":["https://openalex.org/P4310320239"],"host_organization_lineage_names":["Massachusetts Medical Society"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"New England Journal of Medicine","raw_type":"journal-article"},{"id":"pmid:34818475","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/34818475","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"The New England journal of medicine","raw_type":"Journal Article"}],"best_oa_location":null,"sustainable_development_goals":[],"sustainable_development_goals_aurora":[{"id":"https://metadata.un.org/sdg/16","score":0.4300000071525574,"display_name":"Peace, justice, and strong institutions"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":1,"referenced_works":["https://openalex.org/W2791961560"],"related_works":["https://openalex.org/W2394627851","https://openalex.org/W7126446313","https://openalex.org/W2315595045","https://openalex.org/W3006870676","https://openalex.org/W2154609285","https://openalex.org/W3023048253","https://openalex.org/W2415804903","https://openalex.org/W2403791308","https://openalex.org/W3119209976","https://openalex.org/W4252661921"],"abstract_inverted_index":{"The":[0,35],"FDA":[1,42],"has":[2],"long":[3],"taken":[4],"the":[5,25],"legal":[6],"position":[7],"that":[8],"regulated":[9,32],"devices":[10],"could":[11],"also":[12],"be":[13,31],"categorized":[14],"as":[15,33],"drugs.":[16],"But":[17],"according":[18],"to":[19,41],"a":[20,28],"recent":[21],"case,":[22],"products":[23],"meeting":[24],"definition":[26],"of":[27],"device":[29],"\u201cmust":[30],"devices.\u201d":[34],"decision":[36],"comes":[37],"amid":[38],"growing":[39],"challenges":[40],"authority.":[43]},"counts_by_year":[],"updated_date":"2026-10-31T12:09:11.096373","created_date":"2021-12-06T00:00:00"}
