Which documents are required for a class I medical device listing

M

mghaleb

#1
Hi all,

which documents are required or necessary for device listing for class I medical device?

Thanks in advance!
Ghaleb
 
Elsmar Forum Sponsor
J

Julie O

#5
You don't have to submit any documents to FDA to list your device. Instead, you enter a limited amount of information about the device into FDA's online database.

You do have to have various documents on file to support compliance with FDA's requirements for the Class I device you have listed.
 
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