Biomedical Engineering Reference
In-Depth Information
Figure 14.2
Detail from 510(k) search.
states that this application was based on an SE, hence it's summary - #4 - will not only supply
you with a format for the summary but pointers to even more devices with which to claim SE.
14.4.2 Other Sections
All other sections are self-explanatory. As stated previously, the FDA examiners give advice
and their website contains substantial step-by-step instructions.
14.4.3 Process
Once you have submitted your 510(k) application you may wait for months before receiving
a formal examination report. Certainly if you have not stuck to standard format you will be
waiting a long time! Do not be surprised if you receive instructions requiring your submission
to be modified, this is to be expected. The simplest way to remedy any failings is to ask the
examiner for clarification and take it from there. Do not get angry, do not suggest they know
not what they do; this does not help anyone. Instead simply ask them how you can meet their
requirements: this will always reap rewards!
Search WWH ::




Custom Search