M
Hi,
We are developing software for a class II Medical Device. We are adding a small new functionality to software and this change to software is very minimal. The new functionality is independent of other functionalities software. Addition of this functionality will not affect the existing software in any manner. The old software is being approved by FDA and in the market quite some time.
I have following queries:
1. In this scenario, do we need to go for traditional 510(k) or Special 510(k)?
2. What would DHF contain? Only design history of new functionality and impact analysis document to claim that new functionality will not be affecting old functionalities? Or do we need create all the design history documents for all old functionalities also.
Please advice.
Thank you in advance.
Regards,
Manju
+91-9011081376
We are developing software for a class II Medical Device. We are adding a small new functionality to software and this change to software is very minimal. The new functionality is independent of other functionalities software. Addition of this functionality will not affect the existing software in any manner. The old software is being approved by FDA and in the market quite some time.
I have following queries:
1. In this scenario, do we need to go for traditional 510(k) or Special 510(k)?
2. What would DHF contain? Only design history of new functionality and impact analysis document to claim that new functionality will not be affecting old functionalities? Or do we need create all the design history documents for all old functionalities also.
Please advice.
Thank you in advance.
Regards,
Manju
+91-9011081376