FDA Establishment Registration for Software Company

I have been posed with trying to determine the proper path to take in regards to Establishment Registration w/FDA for a Medical Device Software Development Company. The company develops stand alone software that is considered a medical device. The company has multiple buildings located in different cities within the same state. All work is done remotely via computer connecting to servers located in one of the buildings. All quality documentation and records are also located physically on the servers in only one of these buildings. Employees working on the 'medical device' can work in any of these buildings at any time and will have access to all of the necessary tools and documentation to perform their job.

Is it necessary to register all physical facilities? It would seem that the spirit of registering the physical locations is to allow FDA to inspect where the product is manufactured. Software is a bit different in that it is not really manufactured per se. Any precedent here for registering only one of the facilities?

Generally any site where work on the product is done should be registered.

However, and not to scare you, but if you are already selling medical products under the purview of the FDA, these products need to be listed (The Device Listing) before you introduce them into commerce. And now, to add another layer, some of your software products may actually need 510(k)'s. I hope they do not. Or is possible that up to now others, who are already selling the product to the consumer, have been already obtained the necessary market authorizations?

Yes, the product has a 510k approval and is currently listed under the registration for the company. The issue is that the company has expanded its number of facilities beyond the original one and I am wondering about the need to register all facilities based on the fact that it is software being developed and one could argue that the finished device comes together on the server located in only one of these facilities. Not to mention how would/do you handle the fact that in software development we can have users who telecommute from their homes. Seems unnecessary to register all facilities and was looking for feedback or precedent on this.

dd1229 said:

Yes, the product has a 510k approval and is currently listed under the registration for the company. The issue is that the company has expanded its number of facilities beyond the original one and I am wondering about the need to register all facilities based on the fact that it is software being developed and one could argue that the finished device comes together on the server located in only one of these facilities. Not to mention how would/do you handle the fact that in software development we can have users who telecommute from their homes. Seems unnecessary to register all facilities and was looking for feedback or precedent on this.

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Why not ask the FDA? It's a legitimate question and you would get an authoritative answer (hopefully in writing).

Thanks for the response. We might just end up in that position. I was looking for any precedence that may have been set. Some of the advice we have gotten has attempted to use the location of the file servers containing the records and final product as the actual manufacturing facility. We'll see what FDA says.

Would really appreciate the answers that you get from FDA.

.... Good luck!

Conversations with an FDA compliance officer seemed to allude to the fact that registering only the facilities where the servers which house the software and quality records is acceptable. However we are looking for something in writing which should be forthcoming.

Our company has a very similar situation and I was happy to see this conversation! Did you ever receive anything in writing from FDA? If so, would you be able to share it?

Thanks,

Nothing in writing as of yet. A more formal conversation will be taking place soon and will hopefully be followed up by something in writing, although I sense they are not apt to put anything in writing. Will followup here when I get something more definitive from them.