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Pediatric Medical Devices


Tüshaus L, von Sengbusch S, Worringen U, Herting E, Wünsch L, Frielitz F. (2018). Medizinprodukte für Kinder- und Jugendliche: Ein „Niemandsland“ (Pediatric Medical Devices: A "no man's land"). Deutsches Ärzteblatt. 2018. 


Fischer GA, Wells SM, Rebuffoni JF, Peterson BM, LeBien TW. A model for overcoming challenges in academic pediatric medical device innovation. J Clin Transl Sci. 2019. 

Fleurence RL, Forrest CB, Shuren J. Strengthening the Evidence Base for Pediatric Medical Devices Using Real-World Data. J Pediatr. 2019. 

Regulatory Affairs

Off Label Medicine Use

Knopf H, Wolf, IK, Sarganas G, Zhuang W, Rascher W, Neubert A. Off-labelmedicine use in children and adolescents: results of a population-based study in Germany. BMC Public Health 13. 2013. 

Wimmer S, Rascher W, McCarthy S, Neubert A. The EU paediatric regulation: still a large discrepancy between therapeutic needs and approved paediatric investigation plans. Paediatr Drugs. 2014. 


Dooms, MM. Orphan devices: yesterday is history; tomorrow is mystery: towards a European orphan device directive? Orphanet J Rare Dis. 2016. 

Worringen, U. The Humanitarian Device Exemption of the United States as a Pioneering Concept in Orphan Device Regulation and its Implications for the Policy of the Regulation of Medical Devices for Small Populations in the European Union. Wissenschaftliche Prüfungsarbeit zum „Master of Drug Regulatory Affairs“, Bonn. 2015. 


Bleicher EW. Encouraging research and development of pediatric medical devices through legislative and regulatory action: the Pediatric Medical Device Safety and Improvement Act of 2007 in context. Food Drug Law J. 2009. 

Dolcimascolo F. Pediatric cardiac devices--an FDA pediatrician's perspective of the challenges and potential solutions. J Cardiovasc Transl Res. 2009. 

Hwang TJ, Kesselheim AS, Bourgeois FT. Postmarketing trials and pediatric device approvals. Pediatrics. 2014. 

Hwang TJ, Orenstein L, Kesselheim AS, Bourgeois FT. Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act. JAMA Pediatr. 2019. 

Jenkins KJ, Beekman RH, Vitale MG, Hennrikus WL, Minich LL, Ackerman MJ, Berger S, Jaquiss RD, Mahle WT, Marino BS, Vincent JA, Morrow WR, Otsuka NY, Abzug JM, Ganley TJ, Herman MJ, Hyman JE, Segal LS, Shaw BA, Schwend RM. Off-Label Use of Medical Devices in Children. Pediatrics. 2017. 

Samuels-Reid J, Cope JU, Morrison AE. Device safety and effectiveness in the pediatric population: a US FDA perspective. Expert Rev Med Devices. 2009. 

Samuels-Reid J, Lawrence B, Millin C, Cope J. Pediatric devices and adverse events from A to Z: understanding the benefits and risks from a US FDA perspective. Expert Rev Med Devices. 2012. 

Samuels-Reid J  Blake ED. Pediatric medical devices: a look at significant US legislation to address unmet needs. Expert Review of Medical Devices. 2014. 

Ulrich LC, Joseph FD, Lewis DY, Koenig, RL. FDA's pediatric device consortia: national program fosters pediatric medical device development. Pediatrics. 2013. 



Fuerch JH, Sanderson P, Barshi I, Liley H. Developing safe devices for neonatal care. Semin Perinatol. 2019. 

Pediatric Cardiology

Almond CS. The FDA Review Process for Cardiac Medical Devices in Children: A Review for the Clinician. Prog Pediatr Cardiol. 2012.

Beekman RH, Duncan BW, Hagler DJ, Jones TK, Kugler JD, Moore JW, Jenkins KJ; Workgroup on Pediatric Cardiac Devices, Section on Cardiology and Cardiac Surgery, American Academy of Pediatrics. Pathways to approval of pediatric cardiac devices in the United States: challenges and solutions. Pediatrics. 2009. 

Almond CS, Chen EA, Berman MR, Less JR, Baldwin JT, Linde-Feucht SR, Hoke TR, Pearson GD, Jenkins K, Duncan BW, Zuckerman BD. High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices. ASAIO J. 2007.

Joseph F. Pediatric cardiovascular device registries--the need for such data and the potential impact. J Cardiovasc Transl Res. 2010. 

Liberski AR, Butcher JT, Nawrat Z, Golesworthy T, Al Thani DA. Forming effective relationships between academia and the medical devices industry with a focus on launching a smart heart valve prosthesis for pediatric patients. Translational Medicine Communications. 2019. 

Sutherell JS, Hirsch R, Beekman RH. Pediatric interventional cardiology in the United States is dependent on the off-label use of medical devices. 2009. 

Pediatric Orthopedics

Sheha ED, Hammouri Q, Snyder BD, Campbell RM, Vitale MG; POSNA/SRS Task Force for Pediatric Medical Devices. Off-label use of pediatric orthopaedic devices: important issues for the future. J Bone Joint Surg Am. 2014. 

Pediatric Radiology

Daldrup-Link HE, Sammet C, Hernanz-Schulman M, Barsness KA, Cahill AM, Chung E, Doria AS, Darge K, Krishnamurthy R, Lungren MP, Moore S, Olivieri L, Panigrahy A, Towbin AJ, Trout A, Voss S. White Paper on P4 Concepts for Pediatric Imaging. J Am Coll Radiol. 2016.

Pediatric Surgery

Gauderer MW. Creativity and the surgeon. J Pediatr Surg. 2009.

Rothenberg SS. Developing neonatal minimally invasive surgery: Innovation, techniques, and helping an industry to change. J Pediatr Surg. 2015.

Sack BS, Elizondo RA, Huang GO, Janzen N, Espinoza J, Sanz-Cortes M, Dietrich JE, Hakim J, Richardson ES, Oden M, Hanks J, Haridas B, Hury JF, Koh CJ. Pediatric medical device development by surgeons via capstone engineering design programs. J Pediatr Surg. 2018.

Pediatric Urology

Grant M, Stanasel I, Koh CJ. Pediatric medical device consortia: a novel pathway for pediatric device development for pediatric urologists and other pediatric specialists. Urology Practice, 2015.