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FDA's E submitter - For clinical electronic thermometer

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Shawna

Starting to get Involved
#1
#1
For clinical electronic thermometer, I think currently due to the coronavirus pandemic, the 510K could be submitted by e submitter program. However, when I search the e submitter website (FDA eSubmitter ) I can't find the specific product list that could be submitted through e submitter. Any clue for it?
 
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S

Shawna

Starting to get Involved
#3
#3
Ronen, could you do me a favor send me the link about that all medical device types are eligible for 510K submission using eSubmitter. I have spent quite some time searching fda but didn't get that.
 
Ed Panek

Ed Panek

QA RA Small Med Dev Company
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#4
#4
I work for a company that sells thermometers as well. Good luck! There is a lot of demand right now!
 
P

Pads38

Moderator
#6
#6
The FDA link in the OP shows a table of how eSubmissions may be used.
For many devices the office of interest is CDRH Office Device Evaluation. That shows that, at present, any e submission is limited to CD - the eCopy of Ronen's link. The Electronic Submissions Gateway is not yet available for CDRH ODE 510(k).
 
S

Shawna

Starting to get Involved
#7
#7
Pads38 said:
The FDA link in the OP shows a table of how eSubmissions may be used.
For many devices the office of interest is CDRH Office Device Evaluation. That shows that, at present, any e submission is limited to CD - the eCopy of Ronen's link. The Electronic Submissions Gateway is not yet available for CDRH ODE 510(k).
Click to expand...
That is exactly what I understand. Thanks for clarification.
 
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