Which documents are required for a class I medical device listing

mghaleb · Apr 28, 2015

Hi all,

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

Thanks in advance!
Ghaleb

bio_subbu · Apr 28, 2015

Re: class I device listing

mghaleb said:
Hi all,

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

Thanks in advance!
Ghaleb

Hi Ghaleb

Do you have a chance to refer the USFDA's webpage "Device Registration and Listing"?

Also, refer FDA's CDRH learn

1. Regulatory Overview of Device Establishment Registration and Listing

2. Paying the Annual Registration User Fee via the Device Facility User Fee (DFUF) Website

3. FURLS Device Registration and Listing Module Annual Registration

4. FURLS Device Registration and Listing Module for Initial Registration

mghaleb · Apr 30, 2015

Re: class I device listing

Thanks for your help

MIREGMGR · Apr 30, 2015

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

None. Enter the required info online, and you're done.

Julie O · Jun 7, 2015

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.

Which documents are required for a class I medical device listing

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