350 related articles for article (PubMed ID: 28025239)
1. Off-Label Use of Medical Devices in Children.
;
Pediatrics; 2017 Jan; 139(1):. PubMed ID: 28025239
[TBL] [Abstract][Full Text] [Related]
2. Postmarketing trials and pediatric device approvals.
Hwang TJ; Kesselheim AS; Bourgeois FT
Pediatrics; 2014 May; 133(5):e1197-202. PubMed ID: 24733871
[TBL] [Abstract][Full Text] [Related]
3. Quantification of US Food and Drug Administration Premarket Approval Statements for High-Risk Medical Devices With Pediatric Age Indications.
Lee SJ; Cho L; Klang E; Wall J; Rensi S; Glicksberg BS
JAMA Netw Open; 2021 Jun; 4(6):e2112562. PubMed ID: 34156454
[TBL] [Abstract][Full Text] [Related]
4. 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.
Bleicher EW
Food Drug Law J; 2009; 64(3):531-64. PubMed ID: 19999642
[TBL] [Abstract][Full Text] [Related]
5. Off-label use of medical products in radiation therapy: summary of the report of AAPM Task Group No. 121.
Thomadsen BR; Heaton HT; Jani SK; Masten JP; Napolitano ME; Ouhib Z; Reft CS; Rivard MJ; Robin TT; Subramanian M; Suleiman OH
Med Phys; 2010 May; 37(5):2300-11. PubMed ID: 20527564
[TBL] [Abstract][Full Text] [Related]
6. Off-label use of medical devices in radiology: regulatory standards and recent developments.
Smith JJ
J Am Coll Radiol; 2010; 7(2):115-9. PubMed ID: 20142085
[TBL] [Abstract][Full Text] [Related]
7. Medical devices; pediatric uses of devices; requirement for submission of information on pediatric subpopulations that suffer from a disease or condition that a device is intended to treat, diagnose, or cure; direct final rule. Direct final rule.
Food and Drug Administration, HHS
Fed Regist; 2010 Apr; 75(62):16347-51. PubMed ID: 20383921
[TBL] [Abstract][Full Text] [Related]
8. Medical devices; pediatric uses of devices; requirement for submission of information on pediatric subpopulations that suffer from a disease or condition that a device is intended to treat, diagnose, or cure. Final rule.
Food and Drug Administration, HHS
Fed Regist; 2014 Jan; 79(7):1735-41. PubMed ID: 24409553
[TBL] [Abstract][Full Text] [Related]
9. Pediatric cardiac devices--an FDA pediatrician's perspective of the challenges and potential solutions.
Dolcimascolo F
J Cardiovasc Transl Res; 2009 Jun; 2(2):147-9. PubMed ID: 20559980
[TBL] [Abstract][Full Text] [Related]
10. The role of the U.S. Food and Drug Administration in device evaluation and monitoring.
; Diehl DL; Tierney WM; Adler DG; Conway JD; Farraye FA; Kantsevoy SV; Kaul V; Kethu SR; Kwon RS; Mamula P; Pedrosa MC; Rodriguez SA
Gastrointest Endosc; 2010 Jul; 72(1):5-10. PubMed ID: 20421100
[TBL] [Abstract][Full Text] [Related]
11. Pharmaceuticals and medical devices: FDA oversight. End-of-year issue brief.
Chaps NA
Issue Brief Health Policy Track Serv; 2010 Jan; ():1-31. PubMed ID: 20217914
[No Abstract] [Full Text] [Related]
12. Making sense of the food and drug administration.
Connor JA
Semin Pediatr Surg; 2006 Nov; 15(4):293-301. PubMed ID: 17055960
[TBL] [Abstract][Full Text] [Related]
13. The "art" of medicine and the "smokescreen" of the randomized trial off-label use of vascular devices.
Ansel GM; Jaff MR
Catheter Cardiovasc Interv; 2008 Dec; 72(7):998-1002. PubMed ID: 19021289
[TBL] [Abstract][Full Text] [Related]
14. Pediatric circulatory support: an FDA perspective.
Rinaldi JE; Chen EA; Berman MR
ASAIO J; 2005; 51(5):533-5. PubMed ID: 16322713
[TBL] [Abstract][Full Text] [Related]
15. Pathways to approval of pediatric cardiac devices in the United States: challenges and solutions.
Beekman RH; Duncan BW; Hagler DJ; Jones TK; Kugler JD; Moore JW; Jenkins KJ;
Pediatrics; 2009 Jul; 124(1):e155-62. PubMed ID: 19564262
[TBL] [Abstract][Full Text] [Related]
16. FDA medical device approval: things you didn't learn in medical school or residency.
Buch B
Am J Orthop (Belle Mead NJ); 2007 Aug; 36(8):407-12. PubMed ID: 17849025
[TBL] [Abstract][Full Text] [Related]
17. Regulation and Device Development: Tips for Optimizing Your Experience With the Food and Drug Administration.
Brooks SS
Tech Vasc Interv Radiol; 2017 Jun; 20(2):109-115. PubMed ID: 28673647
[TBL] [Abstract][Full Text] [Related]
18. How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?
Samuel AM; Rathi VK; Grauer JN; Ross JS
Clin Orthop Relat Res; 2016 Apr; 474(4):1053-68. PubMed ID: 26584802
[TBL] [Abstract][Full Text] [Related]
19. Food and Drug Administration's perspectives on pediatric cardiac assist devices.
Chen EA; Patel-Raman SM; Berman MR; Zuckerman BD
ASAIO J; 2008; 54(2):147-9. PubMed ID: 18356646
[TBL] [Abstract][Full Text] [Related]
20. Medical Devices; Exemptions From Premarket Notification: Class II Devices. Final order.
Food and Drug Administration, HHS
Fed Regist; 2018 Jun; 83(108):25910-5. PubMed ID: 30019871
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
