FDA unveils 25 initial 510(k) changes, refers controversial recommendations to the Institute of Medicine (IOM).
作者信息
Gilmore Melissa, Hylak-Reinholtz Joseph J
机构信息
McGuire Woods LLP, Washington, DC, USA.
出版信息
Health Care Law Mon. 2011 Jun;2011(6):2-7.
PMID:21748924
Abstract
摘要
相似文献
1
FDA unveils 25 initial 510(k) changes, refers controversial recommendations to the Institute of Medicine (IOM).
Health Care Law Mon. 2011 Jun;2011(6):2-7.
2
IOM tells FDA to develop new regulatory pathway for medical devices.
Am J Health Syst Pharm. 2011 Sep 15;68(18):1672. doi: 10.2146/news110064.
3
Medical devices--balancing regulation and innovation.
N Engl J Med. 2011 Sep 15;365(11):975-7. doi: 10.1056/NEJMp1109094. Epub 2011 Aug 10.
4
Medical devices and health--creating a new regulatory framework for moderate-risk devices.
N Engl J Med. 2011 Sep 15;365(11):977-9. doi: 10.1056/NEJMp1109150. Epub 2011 Aug 10.
5
Combination products neglected by FDA device evaluation.
Nat Med. 2011 Sep 7;17(9):1024. doi: 10.1038/nm0911-1024a.
6
FDA responds to institute of medicine drug safety recommendations--in part.
JAMA. 2007 May 2;297(17):1917-20. doi: 10.1001/jama.297.17.1917.
7
FDA reform: is it enough? After a critical IOM report, agency moves to work harder on drug safety, but Congress presses ahead with its own changes.
Mod Healthc. 2007 Feb 5;37(6):6-7, 1.
8
The FDA and the IOM report.
N Engl J Med. 2007 Dec 13;357(24):2520-1; author reply 2521-2. doi: 10.1056/NEJMc076411.
9
Moving From Substantial Equivalence to Substantial Improvement for 510(k) Devices.
JAMA. 2019 Sep 10;322(10):927-928. doi: 10.1001/jama.2019.10191.
10
The Institute of Medicine report on the FDA: where is the science?
Health Econ. 2007 Mar;16(3):219-21. doi: 10.1002/hec.1222.
Zotero 插件