RT Journal
A1 Voelker R
T1 MOre safety data sought for high-risk devices
JF JAMA
JO JAMA
YR 2009
FD May 13
VO 301
IS 18
SP 1867
OP 1867
DO 10.1001/jama.2009.624
UL http://dx.doi.org/10.1001/jama.2009.624
AB 
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.