How to add a New Factory under a Prior 510K Establishment

[Lynn.Fu]

Hello everyone,

If an establishment owned a 510k,

and now the establishment have a new factory which is a different place but owned by the same company and want to manufacture the same product as cleared in the 510k.

Is the new factory needed to register again ?
could they share the same 510k number?

Thank you

 

[MIREGMGR]

Re: how to add a new factory under a prior establishment?

There are two questions here:

1. Registration of a new facility, owned by an existing company.

2. Changing the manufacturing location of a cleared device.

The first process is straightforward. Go to the FDA DRLM/FURLS website and Register the new facility. Many device makers have multiple facilities Registered.

The second question hinges on whether the new facility provides the same materials, validated processes, etc., and whether anything about the move would trigger a need for a Special 510(k) to update the clearance. Consult FDA guidance K97-1 and the decision-chart contained therein, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080235.htm.

 

[Ronen E]

In principle, a mere location change dose not require a new submission (in other words, the same 510(k) holds). If nothing substantial is changed in the manufacturing process, the new location is as good as the old one. The thing is that occasionally location changes / new facilities do involve some changes in the technology and/or the processes. Sometimes these changes are significant and sometimes they aren't.

Process validation and the likes are applicable to the extent the QSR (21CFR820) is applicable. This is separate to the 510(k) process (21CFR807).