C
Hello,
I am thinking of writing a 510(k) that is purely an expansion of claims. This will not affect our indications for use, as our indications is general enough. My question are:
1) is there any format/guidelines on how to do this? Or, does it follow the typical 510(k) format?.
2) If it follows the typical 510(k) format, is it sufficient to submit simply a literature review (extensive) on the claims for evidence (ie. for lab/bench performance testing results)? Or, will an inhouse clinical study be required? (see background below)
3) Could this be submitted as a special 510(k) as I will not change the wording of the indications itself?
Please help! Thanks!
===================
Some background:
The device I work on is a large imaging medical device. Our current indications for use cover - "..disease states including, but not limited to applications in cardiology, neurology and oncology..". Granted, we mention "..not limited to" to keep our indications general - but we would like to be able to talk about applications in other areas such as: orthopedics, infection, and maybe also mention specific diseases in cardiology, neurology and oncology.
Is a literature review sufficient if additional diseases "claimed" is a widely adopted, well known application of our device?
I am thinking of writing a 510(k) that is purely an expansion of claims. This will not affect our indications for use, as our indications is general enough. My question are:
1) is there any format/guidelines on how to do this? Or, does it follow the typical 510(k) format?.
2) If it follows the typical 510(k) format, is it sufficient to submit simply a literature review (extensive) on the claims for evidence (ie. for lab/bench performance testing results)? Or, will an inhouse clinical study be required? (see background below)
3) Could this be submitted as a special 510(k) as I will not change the wording of the indications itself?
Please help! Thanks!
===================
Some background:
The device I work on is a large imaging medical device. Our current indications for use cover - "..disease states including, but not limited to applications in cardiology, neurology and oncology..". Granted, we mention "..not limited to" to keep our indications general - but we would like to be able to talk about applications in other areas such as: orthopedics, infection, and maybe also mention specific diseases in cardiology, neurology and oncology.
Is a literature review sufficient if additional diseases "claimed" is a widely adopted, well known application of our device?