Mugs..
When FDA issues NSE letter to 510k applicant ..they have a two letter internal code ..which actually describes reason for NSE ..
--------------------------
FB Subject to 515(b) - Requires PMA
NE Not Substantially Equivalent
SC Not Substantially Equivalent - Cannot Market
SL Not Substantially Equivalent - Improper Label
RE Rescind Substantial Equivalence
UD Unable to Determine Equivalence
UO Unable to Determine Equivalence - Outstanding Drug Issue
UR Not Substantially Equivalent - Unreliable Data
OD Unable to Determine Equivalence - Outstanding Device Issue
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When NSE is due to FB ...NSE letter should contain following lines: :
"Furthermore, your device has new technological characteristics that could adversely affect safety and effectiveness and raise new types of safety and effectiveness questions…
Therefore, this device is classified by statute into class III (Premarket Approval), under Section 513(f) of the Federal Food, Drug, and Cosmetic Act (Act).”
I believe ..these line are not present in IMGG NSE letter ..otherwise Dean has to disclose this to public ..as it is big material information.
That mean FDA do not want us to go IDE/PMA route ..they do not think ..that we are class III device.
Most probable NSE code for DVIS is (UD or UR) , i.e unable to determine SE due to missing data or unreliable data ...
I also think that NSE code is not NE also...that means we can stick with predicate device which we used in 510k application.
It is not required to see device actually producing images by FDA...that why truth and accuracy oath letter is all about ..
KKG
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