RT Journal
A1 Braillon A
T1 Medical devices and the approval processes: United states vs france
JF Archives of Internal Medicine
JO Archives of Internal Medicine
YR 2010
FD December 13
VO 170
IS 22
SP 2040
OP 2041
DO 10.1001/archinternmed.2010.454
UL http://dx.doi.org/10.1001/archinternmed.2010.454
AB 
Redberg rightly supported the plans for the new approval process from the US Food and Drug Administration (FDA) for medical devices.1 The FDA has announced it will significantly strengthen its premarket clearance process (which is under review by the Institute of Medicine) and the process for developing and reviewing postmarket data.1 The FDA also has announced a new transparency initiative requiring that clinical data be publicly available. Indeed, a prudent policy is warranted before approval: high-quality clinical data must show that the benefits outweigh the risks.