Anonymous
|
want to determine if a certain device needs fda approval. were do i find fda's definition or criteria for what constituents a medical device?
|
Anonymous
|
In response to Anonymous
To determine if a medical device requires approval review the 21 CFR 814 Premarket Approval of Medical Devices.
In general, if the device does not have a predicate device, it is a new device. Any new device requires Premarket Approval. During the review, the FDA will classify the device and will determine the class requirement.
|
Anonymous
|
In response to Anonymous
I want to find out about Cordis Stent`s, And I don`t know just how to do it
|
Anonymous
|
In response to Anonymous
Does a manufacturer of an FDA approved device have to have product liability insurance, if the product is not manufactured in the US?
|
bloodflowmeasurement
Beginner
Posts: 2
|
In response to
i am also looking for the same,thanks.
|
mobalityaids
Beginner
Posts: 2
|
In response to
Mobility Aids
|
08-07-03 12:48 PM -