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.
320 related articles for article (PubMed ID: 27195383)
1. Medical Device Regulation: A Comparison of the United States and the European Union. Maak TG; Wylie JD J Am Acad Orthop Surg; 2016 Aug; 24(8):537-43. PubMed ID: 27195383 [TBL] [Abstract][Full Text] [Related]
2. Medical device regulation in the United States and the European Union: a comparative study. Chai JY Food Drug Law J; 2000; 55(1):57-80. PubMed ID: 12296349 [No Abstract] [Full Text] [Related]
3. Medical device surveillance world-wide. Badea C; Kolitsi Z; Pallikarakis N; Papapanagiotou A Stud Health Technol Inform; 1996; 28():157-74. PubMed ID: 10184634 [No Abstract] [Full Text] [Related]
4. [Introduction of innovative high-risk medical devices in Europe: are clinical efficacy and safety guaranteed?]. Stordeur S; Vinck I; Neyt M; Van Brabandt H; Hulstaert F Rev Epidemiol Sante Publique; 2013 Apr; 61(2):105-10. PubMed ID: 23477881 [TBL] [Abstract][Full Text] [Related]
5. Legal regulation of the production and trade of medical devices and medical equipment in the EU and US: experience for Ukraine. Pashkov V; Kotvitska A; Harkusha A Wiad Lek; 2017; 70(3 pt 2):614-618. PubMed ID: 28713093 [TBL] [Abstract][Full Text] [Related]
6. A full-fledged overhaul is needed for a risk and value-based regulation of medical devices in Europe. Campillo-Artero C Health Policy; 2013 Nov; 113(1-2):38-44. PubMed ID: 23602548 [TBL] [Abstract][Full Text] [Related]
7. European medical device regulation: a new era? Donawa M Med Device Technol; 2004 Dec; 15(10):30-1. PubMed ID: 16225282 [TBL] [Abstract][Full Text] [Related]
8. How does medical device regulation perform in the United States and the European union? A systematic review. Kramer DB; Xu S; Kesselheim AS PLoS Med; 2012; 9(7):e1001276. PubMed ID: 22912563 [TBL] [Abstract][Full Text] [Related]
9. Electrophysiology devices and the regulatory approval process within the U.S. FDA and abroad. Selzman KA; Patel H; Cavanaugh K J Interv Card Electrophysiol; 2019 Nov; 56(2):173-182. PubMed ID: 31418099 [TBL] [Abstract][Full Text] [Related]
10. How are medical devices regulated in the European Union? French-Mowat E; Burnett J J R Soc Med; 2012 Apr; 105 Suppl 1(Suppl 1):S22-8. PubMed ID: 22508970 [No Abstract] [Full Text] [Related]
11. Ensuring medical device effectiveness and safety: a cross--national comparison of approaches to regulation. Kramer DB; Tan YT; Sato C; Kesselheim AS Food Drug Law J; 2014; 69(1):1-23, i. PubMed ID: 24772683 [TBL] [Abstract][Full Text] [Related]
12. Clinical evaluations clinical investigations under the amended Medical Device Directive. Dannhorn DR; Schwabedissen H Med Device Technol; 2008 Sep; 19(5):16-8, 20. PubMed ID: 18947145 [TBL] [Abstract][Full Text] [Related]
13. Reducing FDA regulations for medical devices: cutting red tape or putting patients' lives at risk? Janetos TM; Xu RS; Walter JR; Xu S Expert Rev Med Devices; 2018 Dec; 15(12):859-861. PubMed ID: 30345824 [No Abstract] [Full Text] [Related]
14. Addressing US and European device testing requirements. Donawa M Med Device Technol; 2008 Sep; 19(5):32, 34-7. PubMed ID: 18947148 [TBL] [Abstract][Full Text] [Related]
15. Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study. Hwang TJ; Sokolov E; Franklin JM; Kesselheim AS BMJ; 2016 Jun; 353():i3323. PubMed ID: 27352914 [TBL] [Abstract][Full Text] [Related]
16. The FDA and the medical device approval process. Guez G; Garg A Dent Implantol Update; 2012 May; 23(5):33-7. PubMed ID: 22594003 [No Abstract] [Full Text] [Related]
17. [Petition of European experts on medical products legislation]. Z Evid Fortbild Qual Gesundhwes; 2013; 107(4-5):347-50. PubMed ID: 24066377 [No Abstract] [Full Text] [Related]
18. Review of the Medical Device Directive. Donawa M Med Device Technol; 2003 Mar; 14(2):20-3. PubMed ID: 12698694 [TBL] [Abstract][Full Text] [Related]