US Overview

What Classifcation is given to the highest risk devices in the US?
Class I
Class III
Class IV
Class II
Class V
What pathway do most Class II devices take in the US?
General Controls
PMA
510(k)
STED
What is the name for the agency which process device applications in the US?
Notified Bodies
FDA
CDRH
US Health Agency
Which is not a part of General Controls
Labeling
Design Controls
Device Listing
Clinical Evidence
What does PMS stand for
Post Market Surveillance
Pre-Market Submission
Protection Managment Submission
All Class II devices submit under a 510(k)
True
Flase
All Class I devices are exempt
True
False
Clinical Studies are required for all US Submissions
True
Flase
An Animal Study is a type of Verification/Validation Method?
True
False
Some 510(k) Submissions include
Special Controls
Clinical Evidence
State of the Art Statements
0
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