The role of the U.S. Food and Drug Administration in device evaluation and monitoring.

Diehl, David L; Tierney, William M; Adler, Douglas G; Conway, Jason D; Farraye, Francis A; Kantsevoy, Sergey V; Kaul, Vivek; Kethu, Sripathi R; Kwon, Richard S; Mamula, Petar; Pedrosa, Marcos C; Rodriguez, Sarah A

Diehl, David L; Tierney, William M; Adler, Douglas G; Conway, Jason D; Farraye, Francis A; Kantsevoy, Sergey V; Kaul, Vivek; Kethu, Sripathi R; Kwon, Richard S; Mamula, Petar; Pedrosa, Marcos C; Rodriguez, Sarah A.

Gastrointest Endosc ; 72(1): 5-10, 2010 Jul.

Article in En | MEDLINE | ID: mdl-20421100

Subject(s)

Device Approval/legislation & jurisprudence; Endoscopes, Gastrointestinal/standards; Equipment Failure; Minimally Invasive Surgical Procedures/instrumentation; Minimally Invasive Surgical Procedures/legislation & jurisprudence; United States Food and Drug Administration/legislation & jurisprudence; Animals; Compassionate Use Trials/legislation & jurisprudence; Endoscopes, Gastrointestinal/classification; Equipment Safety/standards; Humans; Medical Device Recalls/legislation & jurisprudence; Minimally Invasive Surgical Procedures/classification; Off-Label Use/legislation & jurisprudence; Product Surveillance, Postmarketing; United States

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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: United States Food and Drug Administration / Device Approval / Minimally Invasive Surgical Procedures / Endoscopes, Gastrointestinal / Equipment Failure Type of study: Guideline / Prognostic_studies / Systematic_reviews Limits: Animals / Humans Country/Region as subject: America do norte Language: En Journal: Gastrointest Endosc Year: 2010 Type: Article

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