TY  - JOUR
T1  - MEdical device recalls and the fda approval process
AU  - Zuckerman DM, Brown P, Nissen SE
Y1  - 2011/06/13
N1  - 10.1001/archinternmed.2011.30
JO  - Archives of Internal Medicine
SP  - 1006
EP  - 1011
VL  - 171
IS  - 11
N2  - 
In 1938, when the US Congress first mandated that medical products demonstrate safety and effectiveness, the law applied only to drugs, not to medical devices. Congress did not give the US Food and Drug Administration (FDA) the authority to regulate all medical devices until 1976, when it amended the Food, Drug, and Cosmetics Act in response to deaths and infertility caused by the Dalkon Shield and other contraceptive intrauterine devices. Congress and the FDA weighed 2 competing goals during passage of this legislation: providing “the public reasonable assurances of safe and effective devices”1(p1339) while avoiding “overregulation”1(p1339) of the industry.

SN  - 0003-9926
M3  - doi: 10.1001/archinternmed.2011.30
UR  - http://dx.doi.org/10.1001/archinternmed.2011.30
ER  -