As originally asked by Stuart Swibel.

We have a new application that uses most of the same algorithms contained in our existing 510K approved product although this particular application use is not covered in our original 510k filing. Ideally, we would like to provide the new application protocols on a version of our existing device (which is software that runs on standard PC) for investigational research purposes (a quid pro quo since it may help with our product development). The question is whether all the screen labels and other references pertaining to the name of the 510k approved product need to be removed from this version before being provided to the investigational research site? I assume that we will need to have a pop-up window or physically label the equipment with a research only use disclaimer. I’d appreciate any advice anyone has on this subject. Thank you.

Rob Packard
510(k), CE Marking & Quality System Consultant
Good advice from Steve. I would go a bit further though. If you are alpha testing some new software modules you still need to go through the formal channels for obtaining an IDE and your proposed labeling will be reviewed along with the submission. If you don’t do this, any data you gather cannot be used later for a 510(k) submission. If you are a little further along with development and you are at beta testing, then you might consider writing a formal clinical protocol, add forms to capture data, and validate the data entry so that you have formal clinical study data. If you ultimately want to make some claims that are not already being made by predicate software devices, you may need clinical data to obtain 510(k) clearance, This clinical data will also help you sell your new applications. If you need further help from a regulatory consultant, I recommend Mark DuVal. He is an attorney that specializes in 510(k) submissions.

Steve Weisner
President & CEO of Nihon Kohden Innovation Center at Nihon Kohden
First you really need a regulatory consultant. However a few general statements as your mileage may vary. Any investigational device needs to be clearly labeled as such. Yes it can have your previous labels also. The IRB that is covering the usage must clearly define the investigational device (e.g. Same as Model A plus the following changes ….). I would tread cautiously on the letter to file. If there is a change to performance, intended use, etc. you may have moved beyond a letter to file. That’s where a regulatory consultant can coach you.

Linda Hayter
UK Business Unit Manager- Cardiac, Interventional Speciality and Vascular Access divisions
I believe you would need to submit a letter to file for the FDA for any change to an approved product or use of product – they would then assess if you need to do another full submission.