The Regulatory Perspectives on Endoscopic Devices for Obesity.

Autor:	Marrone AK; 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., Antonino MJ; 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., Silverstein JS; 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., Betz MW; 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., Venkataraman-Rao P; 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., Golding M; 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., Cordray D; 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., Cooper JW; 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.
Jazyk:	angličtina
Zdroj:	Gastrointestinal endoscopy clinics of North America [Gastrointest Endosc Clin N Am] 2017 Apr; Vol. 27 (2), pp. 327-341.
DOI:	10.1016/j.giec.2016.12.004
Abstrakt:	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. (Published by Elsevier Inc.)
Databáze:	MEDLINE
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