These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
272 related articles for article (PubMed ID: 16360066)
1. Cardiac resynchronization devices: the Food and Drug Administration's regulatory considerations. Moynahan M; Faris OP; Lewis BM J Am Coll Cardiol; 2005 Dec; 46(12):2325-8. PubMed ID: 16360066 [TBL] [Abstract][Full Text] [Related]
2. 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]
3. The FDA's role in medical device clinical studies of human subjects. Saviola J J Neural Eng; 2005 Mar; 2(1):S1-4. PubMed ID: 15876645 [TBL] [Abstract][Full Text] [Related]
4. An overview of FDA medical device regulation as it relates to deep brain stimulation devices. Peña C; Bowsher K; Costello A; De Luca R; Doll S; Li K; Schroeder M; Stevens T IEEE Trans Neural Syst Rehabil Eng; 2007 Sep; 15(3):421-4. PubMed ID: 17894274 [TBL] [Abstract][Full Text] [Related]
5. Technology assessment of medical devices at the Center for Devices and Radiological Health. Kessler L; Richter K Am J Manag Care; 1998 Sep; 4 Spec No():SP129-35. PubMed ID: 10185989 [TBL] [Abstract][Full Text] [Related]
6. The nightmare of FDA clearance/approval to market: perception or reality? Tylenda CA Technol Health Care; 1996 Sep; 4(3):259-67. PubMed ID: 8931236 [TBL] [Abstract][Full Text] [Related]
7. 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]
9. FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012. Rome BN; Kramer DB; Kesselheim AS JAMA; 2014 Jan 22-29; 311(4):385-91. PubMed ID: 24449317 [TBL] [Abstract][Full Text] [Related]
10. FDA explores new antiretroviral trial designs: interview with David Feigal, M.D. Interview by John S. James. Feigal D AIDS Treat News; 1997 Jun; (No 273):1-5. PubMed ID: 11364399 [TBL] [Abstract][Full Text] [Related]
11. What's next after 50 years of psychiatric drug development: an FDA perspective. Laughren TP J Clin Psychiatry; 2010 Sep; 71(9):1196-204. PubMed ID: 20923624 [TBL] [Abstract][Full Text] [Related]
12. US FDA perspective on regulatory issues affecting circulatory assist devices. Sapirstein W; Chen E; Swain J; Zuckerman B Expert Rev Med Devices; 2006 Nov; 3(6):749-53. PubMed ID: 17280539 [TBL] [Abstract][Full Text] [Related]
13. FDA marketing claims, and the practitioner. Runner S J Evid Based Dent Pract; 2006 Mar; 6(1):19-23. PubMed ID: 17138391 [TBL] [Abstract][Full Text] [Related]
14. Medical device recalls and the FDA approval process. Zuckerman DM; Brown P; Nissen SE Arch Intern Med; 2011 Jun; 171(11):1006-11. PubMed ID: 21321283 [TBL] [Abstract][Full Text] [Related]
15. The issue of a U.S. Food and Drug Administration moratorium on the use of the pulmonary artery catheter. Sprung CL; Eidelman LA New Horiz; 1997 Aug; 5(3):277-80. PubMed ID: 9259343 [TBL] [Abstract][Full Text] [Related]
16. 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]
17. Mechanical devices and US Food and Drug Administration (FDA) approval. Reitz BA Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu; 2006; ():123-7. PubMed ID: 16638557 [TBL] [Abstract][Full Text] [Related]
18. Clinical research and the development of new devices: considerations for nurses. Lanter J Dimens Crit Care Nurs; 2007; 26(3):117-20. PubMed ID: 17440296 [TBL] [Abstract][Full Text] [Related]
19. Assessing the safety and effectiveness of devices after US Food and Drug Administration approval: FDA-mandated postapproval studies. Reynolds IS; Rising JP; Coukell AJ; Paulson KH; Redberg RF JAMA Intern Med; 2014 Nov; 174(11):1773-9. PubMed ID: 25265209 [TBL] [Abstract][Full Text] [Related]