510k Submission for a New Medical Device Product

QM Becky

Involved In Discussions
#1
Good Day All!

We are working on product development for a new product for which we will be submitting a traditional 510(k). We will be launching with one material, and then within about 6 months launching a change to a new material. 2 constraints: a) no, we do not want to delay launch for the new material, and b) no we cannot get production quantities of the new material any sooner.

Original plan was to submit the 510k, and then in 6 months or so submit a special 510k for the material change. We have test sample quantities of both materials and will be testing both materials side by side as we conduct all development and v/v work.

In talking through it today, we wondered if it was possible to submit a single 510k with both materials presented as options and allowing for the device to be made of either? Alternatively, we considered submitting with both materials, but as different models or variations of the device.

Has anyone done this or worked through this type of scenario before? Any insight or guidance is greatly appreciated.

-QMBecky
 
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QM Becky

Involved In Discussions
#3
In this instance, it actually is that different so we will have to submit for it. It will have an impact on labeling and indications for use.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
If the indications for use are different it might be challenging to submit both versions in one 510k, but I wouldn't rule it out upfront. The FDA has issued a guidance document on bundling multiple devices in a single submission but I haven't looked in it for several years. Look it up and have a read.

Good luck,
Ronen.
 
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