Hi,
I have a question surrounding a bundled 510(k) for multiple intended uses which, as of yet, the FDA have been unable to answer.
Unfortunately I can't get into the specifics of what the product is so i'll have to resort to using examples to try to explain my situation.
We have one medical device. However, it is cleared under 3 different 510(k)'s each with a different product code and therefore a different intended use.
We want to launch a new device which has indications for use from all three devices.
Therefore the new device will:
So far I have gathered the following infomration
DICE stated that
The bundling guidance document states that
Based on this information I presume that we would need to pay for and submit multiple bundled 510(k) submissions (1 per each 510(k) review panel). Additionally within the bundled 510(k) submissions we would have three primary predicate devices?
Has anybody else had experience with a similar type of situation?
Thanks all
I have a question surrounding a bundled 510(k) for multiple intended uses which, as of yet, the FDA have been unable to answer.
Unfortunately I can't get into the specifics of what the product is so i'll have to resort to using examples to try to explain my situation.
We have one medical device. However, it is cleared under 3 different 510(k)'s each with a different product code and therefore a different intended use.
We want to launch a new device which has indications for use from all three devices.
Therefore the new device will:
- Be physically identical to all three predicate 510(k) devices
- Have specific indications for use from all three predicate 510(k) devices
- Have three different product codes
- As each product code is reviewed by a different "510(k) review panel" it will also be reviewed by three different FDA review panels.
So far I have gathered the following infomration
DICE stated that
- a single device can have different product codes
- we can't clear a device with three different product codes under a single 510(k) submission because there will be different intended uses.
- they implied that a bundled submission may be appropriate
The bundling guidance document states that
- It is possible to bundle multiple indications for use
- Separate submissions are required if the device is required to be reviewed by multiple 510(k) review panels.
Based on this information I presume that we would need to pay for and submit multiple bundled 510(k) submissions (1 per each 510(k) review panel). Additionally within the bundled 510(k) submissions we would have three primary predicate devices?
Has anybody else had experience with a similar type of situation?
Thanks all