Page 1 of 1
New Device Intake
Device Name
*
Device Category
*
Device Category
A
Diagnostic/IVD
B
Surgical Instrument
C
Implant
D
Therapeutic
E
Imaging/Monitoring
F
Software/SaMD
G
Combination Product (e.g. Drug + Device)
H
Other (Specify)
Target Condition or Disease
*
Is the device powered?
*
Is the device powered?
A
Yes - Electric/Battery
B
Yes - Software Only
C
No- Manual/Mechanical
Is it implanted in the body?
*
Is it implanted in the body?
A
Yes - Permanently
B
Yes - Temporarily
C
No
Intended procedure or clinical use
*
In one sentence, what does this device do during its use?
Your Company Name
*
Grant Program
*
Contact Email
*
Submit
