Which documents are required for a class I medical device listing

[mghaleb]

Hi all,

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

Thanks in advance!
Ghaleb

 

[bio_subbu]

Re: class I device listing

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]

Re: class I device listing

Thanks for your help

 

[MIREGMGR]

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]

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.