title: The Regulatory Perspectives on Endoscopic Devices for Obesity.
abstract: The recent increase in US Food and Drug Administration-approved weight-loss devices has diversified obesity treatment options. The regulatory pathways for endoscopically placed weight-loss devices and considerations for clinical trials are discussed, including the benefit-risk paradigm intended to aid in weight-loss-device trial development. Also discussed is the benefit-risk analysis of recently approved endoscopic devices. A strategic priority of the FDA Center for Devices and Radiological Health is to increase the use of patient input in decision making. Thus, we consider how endoscopic weight-loss devices with profiles similar to those that have been approved may be viewed in a patient preference study.
authors.affiliation: Gastroenterology Devices Branch of the Division of Reproductive Gastro-Renal and Urological Devices, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Building 66, Room G218, Silver Spring, MD 20993-0002, USA. Electronic address: April.Marrone@fda.hhs.gov.
authors.forename: April K
authors.initials: AK
authors.lastname: Marrone
authors.affiliation: Gastroenterology Devices Branch of the Division of Reproductive Gastro-Renal and Urological Devices, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Building 66, Room G218, Silver Spring, MD 20993-0002, USA.
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Antonino
authors.affiliation: Gastroenterology Devices Branch of the Division of Reproductive Gastro-Renal and Urological Devices, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Building 66, Room G218, Silver Spring, MD 20993-0002, USA.
authors.forename: Joshua S
authors.initials: JS
authors.lastname: Silverstein
authors.affiliation: Gastroenterology Devices Branch of the Division of Reproductive Gastro-Renal and Urological Devices, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Building 66, Room G218, Silver Spring, MD 20993-0002, USA.
authors.forename: Martha W
authors.initials: MW
authors.lastname: Betz
authors.affiliation: Gastroenterology Devices Branch of the Division of Reproductive Gastro-Renal and Urological Devices, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Building 66, Room G218, Silver Spring, MD 20993-0002, USA.
authors.forename: Priya
authors.initials: P
authors.lastname: Venkataraman-Rao
authors.affiliation: Gastroenterology Devices Branch of the Division of Reproductive Gastro-Renal and Urological Devices, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Building 66, Room G218, Silver Spring, MD 20993-0002, USA.
authors.forename: Martin
authors.initials: M
authors.lastname: Golding
authors.affiliation: Gastroenterology Devices Branch of the Division of Reproductive Gastro-Renal and Urological Devices, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Building 66, Room G218, Silver Spring, MD 20993-0002, USA.
authors.forename: Diane
authors.initials: D
authors.lastname: Cordray
authors.affiliation: Gastroenterology Devices Branch of the Division of Reproductive Gastro-Renal and Urological Devices, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Building 66, Room G218, Silver Spring, MD 20993-0002, USA.
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Cooper
mesh_terms: D050110:Bariatric Surgery / Q000295:instrumentation* / Q000331:legislation & jurisprudence; D003657:Decision Making; D018795:Device Approval; D016099:Endoscopy, Gastrointestinal / Q000295:instrumentation* / Q000331:legislation & jurisprudence; D006801:Humans; D009765:Obesity / Q000601:surgery*; D057240:Patient Preference; D014481:United States
keywords: Endoscopic; Gastric emptying; Intragastric balloon; Medical device; Obesity; Regulatory; Weight loss