How to submit Pre-submission to FDA?

Brian K

Starting to get Involved
#1
Hello

I wonder the way to submit pre-submission for medical device to FDA.

I have checked all required document list but haven't noticed submission protocol.
 
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monoj mon

Quite Involved in Discussions
#2
Hello

I wonder the way to submit pre-submission for medical device to FDA.

I have checked all required document list but haven't noticed submission protocol.
I assume you are asking about submitting it to CDRH and I assume you are asking about how to submit the package to the FDA.

Based on these assumptions I would say submit a valid eCopy to CDRH Document control center at the following address.

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Control Center (DCC) – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

Follow these guidance,

1. For Q-sub
2. For eCopy
 

Brian K

Starting to get Involved
#3
Thank you for reply

Pre-submission documents is only accepted via eCopy such as CD, DVD?
Is there another way to submit via softcopy?
 
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