In the traditional 510(k) submission of a software, there are some items about voluntary consensus standards in the RTA checklist. According to the guidance, if you have utilized FDA-recognized consensus standards, you must submit a DOC and list the standards in the DOC. And if we don't utilized FDA-recognized consensus standards, does that mean we needn't to prepare a DOC or DOC is needed, but the part of standard can be omitted.
At the beginning, we thought the voluntary consensus standards were the FDA guidance relevant. Now I am aware of it refers to some EU standards such as ISO or IEC standards. all the content of the submission are prepared according to the FDA guidance except a risk management, which is prepared according to the ISO 14971.
So now there two difficulties:
How can we deal the problem about the voluntary consensus standards ?
And if we submit a DOC containing a consensus standards of ISO 14971, whether FDA will request supplement documentation to support this DOC?
if there are some misunderstanding of the guidance above, I would appreciate you point it out!
At the beginning, we thought the voluntary consensus standards were the FDA guidance relevant. Now I am aware of it refers to some EU standards such as ISO or IEC standards. all the content of the submission are prepared according to the FDA guidance except a risk management, which is prepared according to the ISO 14971.
So now there two difficulties:
How can we deal the problem about the voluntary consensus standards ?
And if we submit a DOC containing a consensus standards of ISO 14971, whether FDA will request supplement documentation to support this DOC?
if there are some misunderstanding of the guidance above, I would appreciate you point it out!