Regulatory Open Forum

Hi everyone,

I am wondering if anyone might be able to provide some help for the following two scenarios.

Scenario A: We purchase a device that was FDA cleared and is manufactured by another company.  Before this item is sold we apply our own labeling. Should I enter the 510(k) number for the other company into the GUDID for this item even though we are the labeler and are selling it under our brand name?

Scenario B:  For one of our kits we package together our own FDA cleared device with a device cleared by a different manufacturer (i.e. items from scenario A above).  Should we be entering our 510(k) number and the 510(k) number of the other manufacturer into the GUDID for this kit?  Or should we only enter our own 510(k) number because that is the brand name that these items are being sold under?

Any input that can be provided would be greatly appreciated!!

In Scenario A you are a relabeler, see 830.60, so you will assign a new DI and keep a record showing the relationship of the prior DI to your new DI.

Your label will have your UDI, not the other company’s.

You will create a DI Record in GUDID for your new DI. The “FDA Premarket Submission Number” field should be the number under which FDA cleared it for the other company.

In Scenario B, you have a kit. The DI Record describes the kit, and doesn’t include anything in the kit. (You could describe the kit’s contents in the DI Record’s Device Description field.)

You will create a DI Record for the kit, and put a UDI on the kit’s label.

The question then becomes whether you can legally market the kit; the kit wasn’t cleared on its own, and therefore doesn’t have a 510(k). Assuming there are no issues, the DI Record field “Device Exempt from Premarket Submission” is Yes and the “FDA Premarket Submission Number” field is blank. Since the kit presumably doesn’t need a 510(k) number, there is no number to enter.

In the kit’s DI Record, the “Kit” field is Yes and the “Device Count” is 1 since there is only 1 kit in the base package.

Hi everyone,

I am wondering if anyone might be able to provide some help for the following two scenarios.

Scenario A: We purchase a device that was FDA cleared and is manufactured by another company.  Before this item is sold we apply our own labeling. Should I enter the 510(k) number for the other company into the GUDID for this item even though we are the labeler and are selling it under our brand name?

Scenario B:  For one of our kits we package together our own FDA cleared device with a device cleared by a different manufacturer (i.e. items from scenario A above).  Should we be entering our 510(k) number and the 510(k) number of the other manufacturer into the GUDID for this kit?  Or should we only enter our own 510(k) number because that is the brand name that these items are being sold under?

Any input that can be provided would be greatly appreciated!!

Thank you for your reply Dan,

Some additional information for Scenario B.  When we did our FDA submission we included these 3rd party items as part of the submission, so I believe they are cleared to be legally marketed by our company.  I just want not sure if we should list our 510k number for the kit or if we should list our 510k number plus the 3rd party 510k number.

The information you provided for Scenario A makes sense and is helpful, Thanks!

In Scenario A you are a relabeler, see 830.60, so you will assign a new DI and keep a record showing the relationship of the prior DI to your new DI.

Your label will have your UDI, not the other company’s.

You will create a DI Record in GUDID for your new DI. The “FDA Premarket Submission Number” field should be the number under which FDA cleared it for the other company.

In Scenario B, you have a kit. The DI Record describes the kit, and doesn’t include anything in the kit. (You could describe the kit’s contents in the DI Record’s Device Description field.)

You will create a DI Record for the kit, and put a UDI on the kit’s label.

The question then becomes whether you can legally market the kit; the kit wasn’t cleared on its own, and therefore doesn’t have a 510(k). Assuming there are no issues, the DI Record field “Device Exempt from Premarket Submission” is Yes and the “FDA Premarket Submission Number” field is blank. Since the kit presumably doesn’t need a 510(k) number, there is no number to enter.

In the kit’s DI Record, the “Kit” field is Yes and the “Device Count” is 1 since there is only 1 kit in the base package.

Hi everyone,

I am wondering if anyone might be able to provide some help for the following two scenarios.

Scenario A: We purchase a device that was FDA cleared and is manufactured by another company.  Before this item is sold we apply our own labeling. Should I enter the 510(k) number for the other company into the GUDID for this item even though we are the labeler and are selling it under our brand name?

Scenario B:  For one of our kits we package together our own FDA cleared device with a device cleared by a different manufacturer (i.e. items from scenario A above).  Should we be entering our 510(k) number and the 510(k) number of the other manufacturer into the GUDID for this kit?  Or should we only enter our own 510(k) number because that is the brand name that these items are being sold under?

Any input that can be provided would be greatly appreciated!!