Mechanical devices and US Food and Drug Administration (FDA) approval

Seminars in Thoracic and Cardiovascular Surgery. Pediatric Cardiac Surgery Annual
Bruce A Reitz

Abstract

Long-term ventricular assist devices for adults have advanced far more than have suitable devices for neonates and infants. The difficulties of design and construction of miniaturized blood pumping systems and the high costs associated with developing, testing, and approval of such devices has been prohibitive. Still, there is an important clinical need for such devices as the availability of donor hearts for this age group has been especially limited. Recently, several pneumatic pulsatile pumps have been developed based on the adult experience, and the issues of regulatory approval are now assuming greater importance for these devices. This chapter reviews the current system for medical device classification and the approval processes in the United States and in Europe. This system is continually evolving, with dedicated and knowledgeable professionals charged with assuring the efficacy, safety, appropriate labeling, and continuing surveillance of approved devices. Pediatric cardiac surgeons involved in transplantation and assist devices need to be aware of the regulatory issues, and work with manufacturers and governmental agencies to make sure that successful devices are available as soon as possible for their patients.

References

Feb 27, 1999·The Journal of Thoracic and Cardiovascular Surgery·B W DuncanJ M Wilson
Jan 17, 2002·The New England Journal of Medicine·E A RoseUNKNOWN Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) Study Group
Dec 6, 2003·ASAIO Journal : a Peer-reviewed Journal of the American Society for Artificial Internal Organs·Olaf ReinhartzDavid J Farrar
Jun 14, 2005·European Journal of Cardio-thoracic Surgery : Official Journal of the European Association for Cardio-thoracic Surgery·Brigitte StillerRoland Hetzer
Aug 17, 2005·The Journal of Heart and Lung Transplantation : the Official Publication of the International Society for Heart Transplantation·Mark M BoucekMarshall I Hertz
Dec 3, 2005·ASAIO Journal : a Peer-reviewed Journal of the American Society for Artificial Internal Organs·Michiaki ImamuraJonathan J Drummond-Webb

❮ Previous
Next ❯

Citations

Nov 3, 2010·European Child & Adolescent Psychiatry·J GrahamUNKNOWN European Guidelines Group
Apr 21, 2010·Journal of Materials Science. Materials in Medicine·H B MachadoJ A Covas
Oct 29, 2003·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Shane R NeedhamWilliam D Korte
Jan 1, 2014·Journal of Controlled Release : Official Journal of the Controlled Release Society·Raghu Raj Singh ThakurDavid S Jones
Jan 30, 2014·Lung Cancer : Journal of the International Association for the Study of Lung Cancer·Cathal P O'BrienStephen P Finn
Sep 1, 2005·Meat Science·R A Mancini, M C Hunt
Jun 18, 2003·European Journal of Radiology·H ImhofR Nowotny
Jun 25, 2002·Methods : a Companion to Methods in Enzymology·B Lauren CharousK Kelly
Sep 3, 2011·Pathology International·Akira IshiharaNaoto Kuroda
May 6, 2014·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Frank M C Besag
Mar 19, 2014·European Journal of Pharmacology·Roman V Frolov, Satpal Singh
Apr 18, 2007·Current Rheumatology Reports·Imran Iqbal, Roy Fleischmann
Mar 25, 2008·Therapeutics and Clinical Risk Management·Monali J Bhosle, Rajesh Balkrishnan
Apr 5, 2014·Research in Nursing & Health·Glenda N LindsethPaul D Lindseth
Sep 25, 2008·ASAIO Journal : a Peer-reviewed Journal of the American Society for Artificial Internal Organs·S Adil HusainMark W Turrentine
Jul 9, 2010·ASAIO Journal : a Peer-reviewed Journal of the American Society for Artificial Internal Organs·Carlo R BartoliSteven C Koenig
Feb 27, 2020·Circulation Journal : Official Journal of the Japanese Circulation Society·Monika GawałkoJędrzej Kosiuk
Jul 18, 2015·The Cochrane Database of Systematic Reviews·Jesús López-AlcaldeXavier Bonfill Cosp
Apr 17, 2019·Nature Reviews. Gastroenterology & Hepatology·Gerard CumminsAnastasios Koulaouzidis
May 3, 2019·Environmental Science and Pollution Research International·Allyson Q da Silva, Denis Moledo de Souza Abessa
Mar 4, 2020·JAMA Internal Medicine·Robert Steinbrook
Jan 11, 2016·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Abeed SarkerGraciela Gonzalez
Jan 9, 2010·International Journal of Toxicology·Valerie RobinsonF Alan Andersen
Mar 7, 2020·Journal of Neurology, Neurosurgery, and Psychiatry·Douglas L ArnoldUNKNOWN PARADIGMS Study Investigators
May 12, 2010·Nature Biotechnology·William B MattesRaymond L Woosley
Oct 4, 2017·American Journal of Pharmaceutical Education·Tracy M KosinskiPedro J Zavala
Jan 19, 2012·American Journal of Medical Genetics. Part C, Seminars in Medical Genetics·Emanuela LacanáAmy S Rosenberg
Jul 5, 2019·European Journal of Clinical Pharmacology·Carlos AlvesFrancisco Batel Marques
Mar 21, 2020·Journal of Clinical Pharmacology·Savannah J McFeelyIsabelle Ragueneau-Majlessi
Aug 5, 2020·JAMA : the Journal of the American Medical Association
Jul 13, 2020·Clinical Pharmacology and Therapeutics·Jennifer J GaoRichard Pazdur
Mar 5, 2016·The Cochrane Database of Systematic Reviews·Andrea SiebenhoferThomas Semlitsch
Sep 29, 2019·Clinical Journal of the American Society of Nephrology : CJASN·Joseph V BonventreMurray Sheldon
Jul 9, 2016·Nature Reviews. Cancer·Ashley J Vargas, Curtis C Harris

❮ Previous
Next ❯

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