FDA guidance on Foreign establishment registration

[Evans J]

Could someone please confirm my interpretation of the FDA guidance?

We are a UK company that has designed, tested and had a successful 510k submission of a non implantable theraputic medical device. We are going to contract out the procurement of components and the assembly, test and shipment of our product to a company that is located in the US and is US owned.

Does that make us a specification developer or a manufacturer?
From the almost helpful FDA definitions it would appear that we qualify as specification developer, but as it is our design and 510k and that we are accountable does this not make us the manufacturer?

A clearer insight would be appreciated

 

[maaquilino]

You're correct that as it's your design and 510k that you are accountable and are the manufacturer.

If you look at the preamble to CFR820 and do a search for manufacturer you can get the FDA's thinking on this.

http://www.fda.gov/MedicalDevices/D...ments/QualitySystemsRegulations/ucm230127.htm

From the link above:

"However, FDA disagrees that contract sterilizers, installers, specification developers, repackagers, relabelers, and initial distributors should be deleted from the definition, primarily because all such persons may have a significant effect on the safety and effectiveness of a device and on the public health. All persons who perform these functions meet the definition of manufacturer, and therefore should be inspected to ensure that they are complying with the applicable provisions. For example, a specification developer initiates the design requirements for a device that is manufactured by a second party for subsequent commercial distribution. Such a developer is subject to design controls. Further, those that perform the functions of contract sterilization, installation, relabeling, remanufacturing, and repacking have routinely been considered to be manufacturers under the original CGMP definition, and the agency has treated them as such by inspecting them to ensure that they comply with the appropriate portions of the original CGMP. By explicitly including them in the definition of ``manufacturer'' the agency has simply codified its longstanding policy and interpretation of the original regulation."

The FDA's definition of a manufacturer from CFR 820 - "Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions."

 

[Ronen E]

Hello and welcome to (posting on) the Cove

1. Specification Developers are a specific type of Manufacturer. If you are the former, you're also the latter.

2. Who the responsible manufacturer is depends on the labelling, not on 510(k) title. Who is named on the labeling? Does the labeling include the "manufactured for / distributed by" terminology? If your name is (duely) not mentioned on the labeling, and you don't take part in manufacturing, you can't be held the regulatorily responsible manufacturer. If it is mentioned, the answer depends on the details.

Cheers,
Ronen.

 

[Evans J]

Thank you all. Manufacturer it is then.