Ressources

Review

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.
https://www.aerzteblatt.de/pdf.asp?id=202835 

Innovation

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.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6676500/https>https://www.ncbi.nlm.nih.gov/pubmed/31378521https 

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.
https://www.ncbi.nlm.nih.gov/pubmed/23822744 

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.
https://www.ncbi.nlm.nih.gov/pubmed/25056717https>https://www.ncbi.nlm.nih.gov/pubmed/26939863https 

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.

FDA

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.
https 

Dolcimascolo F. Pediatric cardiac devices--an FDA pediatrician's perspective of the challenges and potential solutions. J Cardiovasc Transl Res. 2009.
https://www.ncbi.nlm.nih.gov/pubmed/20559980 

Hwang TJ, Kesselheim AS, Bourgeois FT. Postmarketing trials and pediatric device approvals. Pediatrics. 2014.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4531281/https>https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/30452498/https 

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.<br />

https 

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.
https://www.ncbi.nlm.nih.gov/pubmed/22702258 

Samuels-Reid J  Blak

Pediatric medical devices: a look at significant US legislation to address unmet needs. Expert Review of Medical Devices. 2014.

Neonatology

Fuerch JH, Sanderson P, Barshi I, Liley H. Developing safe devices for neonatal care. Semin Perinatol. 2019.
https://www.ncbi.nlm.nih.gov/pubmed/31662216 

Pediatric Cardiology

Almond CS. The FDA Review Process for Cardiac Medical Devices in Children: A Review for the Clinician. Prog Pediatr Cardiol. 2012.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3363973/https>https://www.ncbi.nlm.nih.gov/pubmed/19564262https 

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.
https 

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.
https://link.springer.com/article/10.1186/s41231-019-0046-3 

Sutherell JS, Hirsch R, Beekman RH. Pediatric interventional cardiology in the United States is dependent on the off-label use of medical devices. 2009.
https://www.ncbi.nlm.nih.gov/pubmed/20136851https>https://www.ncbi.nlm.nih.gov/pubmed/24500593https 

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.<br />

https

Rothenberg SS. Developing neonatal minimally invasive surgery: Innovation, techniques, and helping an industry to change. J Pediatr Surg. 2015.
https://www.ncbi.nlm.nih.gov/pubmed/25638608

Sack BS, Elizondo RA, Huang GO, Janzen N, Espinoza J, Sanz-Cortes M, Dietrich JE, Hakim J, Richardson ES, Oden M, Hanks J, H

Pediatric medical device development by surgeons via capstone engineering design programs. J Pediatr Surg. 2018.