TY  - JOUR
T1  - MOre safety data sought for high-risk devices
AU  - Voelker R
Y1  - 2009/05/13
N1  - 10.1001/jama.2009.624
JO  - JAMA
SP  - 1867
EP  - 1867
VL  - 301
IS  - 18
N2  - 
The FDA's request covers Class 3 devices, which pose the greatest risk to consumers from among 3 categories of medical devices. Class 1 devices include such low-risk items as tongue depressors; Class 2 devices such as thermometers pose medium risks. The Class 3 devices covered in the FDA's request for data include hip joints, spinal screws, an automated external defibrillator, an electroconvulsive therapy device, and a number of cardiac pacemaker parts.

SN  - 0098-7484
M3  - doi: 10.1001/jama.2009.624
UR  - http://dx.doi.org/10.1001/jama.2009.624
ER  -