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The Food and Drug Administration's (FDA's) 510(k) Process: A Systematic Review of 1000 Cases.
Shah, Puja; Olavarria, Oscar; Dhanani, Naila; Ciomperlik, Hailie; Mohr, Cassandra; Bernardi, Karla; Neela, Niharika; Coelho, Rainna; Ali, Zuhair; Prabhu, Ajita; Liang, Mike K.
Afiliação
  • Shah P; Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, Texas.
  • Olavarria O; Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, Texas; Center for Surgical Trials and Evidence-Based Practice, McGovern Medical School at UTHealth, Houston, Texas.
  • Dhanani N; Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, Texas; Center for Surgical Trials and Evidence-Based Practice, McGovern Medical School at UTHealth, Houston, Texas.
  • Ciomperlik H; Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, Texas.
  • Mohr C; Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, Texas.
  • Bernardi K; Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, Texas; Center for Surgical Trials and Evidence-Based Practice, McGovern Medical School at UTHealth, Houston, Texas.
  • Neela N; Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, Texas.
  • Coelho R; Department of Clinical Sciences, College of Medicine, University of Houston, Texas; Department of Surgery, Graduate Medical Education, HCA Healthcare Kingwood, Kingwood, Texas.
  • Ali Z; Department of Clinical Sciences, College of Medicine, University of Houston, Texas; Department of Surgery, Graduate Medical Education, HCA Healthcare Kingwood, Kingwood, Texas. Electronic address: zuhair.ali@hcahealthcare.com.
  • Prabhu A; Department of Surgery, Cleveland Clinic, Ohio.
  • Liang MK; Department of Clinical Sciences, College of Medicine, University of Houston, Texas; Department of Surgery, Graduate Medical Education, HCA Healthcare Kingwood, Kingwood, Texas.
Am J Med ; 136(2): 172-178.e14, 2023 02.
Article em En | MEDLINE | ID: mdl-36170936
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Aprovação de Equipamentos / Medicamentos sob Prescrição Tipo de estudo: Clinical_trials / Systematic_reviews Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Am J Med Ano de publicação: 2023 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Aprovação de Equipamentos / Medicamentos sob Prescrição Tipo de estudo: Clinical_trials / Systematic_reviews Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Am J Med Ano de publicação: 2023 Tipo de documento: Article