Convenience Kits - FDA Registration Responsibilities and Requirements

[AJayC]

FDA FACILITY REGISTRATION QUESTION:
Would our company be the repackager/relabler of the kits or the specification developer of convenience kits?

Our company manufacturers labels which are not medical devices. These labels are added to convenience kits and sold under our company name.

- Our company hires a kit assembler to assemble the convenience kits for medical procedures.
- Kit assembler adds our labels and a pen, with other items which are then sent to a sterilizing company.
- Kit assembler does not manufacturer any item in the kit.
- The kits are sold under our company's name.

What would be our registration activity - repackager/relabler OR specification developer ?

 

[MIREGMGR]

There are several ways for this situation to be legally structured.

Is the external party registered with FDA? Are they and you within the US? Are the kits at least partly intended for the US market? If there's sterilization involved, who does it?

Assuming "yes" and "yes" for the 2nd and 3rd questions and that any sterilization isn't done by the external party, probably you are the regulatorily responsible party for the kits...either as a specification provider, or a manufacturer, or under the kit packer category--it doesn't really matter what descriptor is used, as long as responsibility is assigned...and the external party is a contract manufacturer and has no regulatory responsibility. (Or secondary responsibility if they're a registered device establishment.)

Do you have a Supplier Agreement with the external party? What does it say about regulatory responsibility?

 

[AJayC]

The Kit assembler is an FDA registered company as both a contract manufacturer and relabeler/repackager. Sterilization is done by a sterilization company and returned to the kit assembler who then distributes the kits within the USA with our company label.

I have not seen the supplier agreement. We recently merged with a company that uses the kit assembler and are working on what the company's responsibilities should be for various devices.

 

[MIREGMGR]

...who then distributes the kits within the USA with our company label.

This is important as it causes the external party have a parallel registration and listing responsibility.

I had assumed from your prior information that they returned the kits to you and you distributed.

An additional relevant question is, who handles the reporting of adverse events?

In any case, your question was in regard to requirements applicable to you. The most likely scenario is that you are responsible for the products, with a requirement to register and list. The other possible scenario is if the external party sees the products as theirs, with you as a private-label distributor-in-name-only, but them doing the physical distribution. That however would not seem to be consistent with your description of "hiring" the external party to do the kit packing.

 

[AJayC]

Thanks for your help. It appears the company will need to list as a Spec. Developer, list with the FDA, and pay the facility registration fee for 2012.

 

[Sandman2002]

Your tread sparked my interest. I have a new Medical device Company that will be selling a convenience Kit. We will be packaging drugs and our disposable in a kit (no relabeling) I would love a recommendation if you are happy with your company. I'm also curious about the distribution, it sounds like your company is able to assist in this as well?