Regulatory Open Forum

Hello,

Is there an FDA database where one can get more information(information about indications for use, device description ) about  class I medical devices that are exempt from a premarket notification application and FDA clearance? Right now I can only see information on the Establishment Registration & Device Listing database where you can only see the product code and the regulation no.

Thanks a lot. Your help is much appreciated!

The classification database is a handy place to look up those product codes and regulation numbers, linking to the regulations that describe them.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm

The UDI database is also an interesting place to look. It shows you some related characteristics of actual devices that are listed under those codes.

https://accessgudid.nlm.nih.gov/

Hello,

Is there an FDA database where one can get more information(information about indications for use, device description ) about  class I medical devices that are exempt from a premarket notification application and FDA clearance? Right now I can only see information on the Establishment Registration & Device Listing database where you can only see the product code and the regulation no.

Thanks a lot. Your help is much appreciated!

Anon,

Not sure what you are looking for, but there are three databases - the UDI and classification Anne mentioned.

There is also the Establishment Registration database.  Once you have the Product Code for the Class I, Exempt device, you can look up on that database to see which companies have registered products under that Product Code.

The classification database is a handy place to look up those product codes and regulation numbers, linking to the regulations that describe them.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm

The UDI database is also an interesting place to look. It shows you some related characteristics of actual devices that are listed under those codes.

https://accessgudid.nlm.nih.gov/

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 15-Sep-2023 15:08
From: Anonymous Member
Subject: FDA database for Class I medical devices

This message was posted by a user wishing to remain anonymous

Hello,

Is there an FDA database where one can get more information(information about indications for use, device description ) about  class I medical devices that are exempt from a premarket notification application and FDA clearance? Right now I can only see information on the Establishment Registration & Device Listing database where you can only see the product code and the regulation no.

Thanks a lot. Your help is much appreciated!

The classification database is a handy place to look up those product codes and regulation numbers, linking to the regulations that describe them.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm

The UDI database is also an interesting place to look. It shows you some related characteristics of actual devices that are listed under those codes.

https://accessgudid.nlm.nih.gov/

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 15-Sep-2023 15:08
From: Anonymous Member
Subject: FDA database for Class I medical devices

This message was posted by a user wishing to remain anonymous

Hello,

Is there an FDA database where one can get more information(information about indications for use, device description ) about  class I medical devices that are exempt from a premarket notification application and FDA clearance? Right now I can only see information on the Establishment Registration & Device Listing database where you can only see the product code and the regulation no.

Thanks a lot. Your help is much appreciated!

Hello,

Is there an FDA database where one can get more information(information about indications for use, device description ) about  class I medical devices that are exempt from a premarket notification application and FDA clearance? Right now I can only see information on the Establishment Registration & Device Listing database where you can only see the product code and the regulation no.

Thanks a lot. Your help is much appreciated!

Hello Anon,

I can run a report out of SOFIE (our database) for you.  There are 122,003 exempt device listings.  Listings do not have IFU statements, but some (13,243) have a 510(k) or De Novo submission number listed.  Some of those would have a summary available.  

That 122K covers all types of devices.  We can narrow it down for you by regulation, classification panel, or specific product codes.  Let me know if this would be helpful.

Cheers,

Melissa

Hello,

Is there an FDA database where one can get more information(information about indications for use, device description ) about  class I medical devices that are exempt from a premarket notification application and FDA clearance? Right now I can only see information on the Establishment Registration & Device Listing database where you can only see the product code and the regulation no.

Thanks a lot. Your help is much appreciated!

Hello,

Is there an FDA database where one can get more information(information about indications for use, device description ) about  class I medical devices that are exempt from a premarket notification application and FDA clearance? Right now I can only see information on the Establishment Registration & Device Listing database where you can only see the product code and the regulation no.

Thanks a lot. Your help is much appreciated!

If you use FDA's Product Classification database and under the drop down menu for submission type, select 510(k) exempt, and under device, type in the device, you may find helpful information. A search for a 510(k) exempt submission type alone retrieves a lot of results for class I and class II 510(k) exempt devices. In viewing a 510(k) exempt device search result, this contains the product code, regulation (which gives an identification of the device and its classification), etc.

Hello,

Is there an FDA database where one can get more information(information about indications for use, device description ) about  class I medical devices that are exempt from a premarket notification application and FDA clearance? Right now I can only see information on the Establishment Registration & Device Listing database where you can only see the product code and the regulation no.

Thanks a lot. Your help is much appreciated!