RT Journal
A1 Zuckerman DM, Brown P, Nissen SE
T1 FDa recalls not as alarming as they seem—reply
JF Archives of Internal Medicine
JO Archives of Internal Medicine
YR 2011
FD June 13
VO 171
IS 11
SP 1044
OP 1046
DO 10.1001/archinternmed.2011.243
UL http://dx.doi.org/10.1001/archinternmed.2011.243
AB 
Current law requires the FDA to use their more rigorous review, the PMA process, if a medical device is life sustaining or otherwise high risk.1 The 510(k) process is intended for devices that are lower or moderate risk.1 We pointed out that if a medical device can severely injure or kill patients when it fails, then it is not a low- or moderate-risk device and should have been approved through the PMA process. Unfortunately, the FDA designates many new devices as moderate risk and clears them through the 510(k) process but later recalls the devices after they kill or seriously injure patients. Most high-risk recalls are caused by predictable problems (such as implant breakage, deterioration, or manufacturing defects); therefore, there should be few high-risk recalls among devices that are truly low or moderate risk.