These regulations implement FDA's responsibilities and authority concerning the reports of corrections and removals provisions of the [[Safe Medical Devices Act]] of the 1990 (the SMDA).
The FDA requires manufacturers, importers and distributors to report any corrections or removals of a device undertaken to:
* Reduce a risk to health
* Remedy of a risk to health.
Compliance to safety is a highly important item during an [[FDA Inspection]]
bag
fda_public
created
Sat, 23 Jun 2012 18:23:00 GMT
creator
dirkjan
modified
Sat, 23 Jun 2012 18:23:00 GMT
modifier
dirkjan
tags
CFR
FDA
creator
dirkjan