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Which guidance do you use for guiding the requirements of IFU for 510(k) submission?

Ashley Fu

Starting to get Involved
#1
I have found some document about the labelling, such as
Labeling Regulatory Requirements for Medical Devices and IMDRF/GRRP WG/N52 FINAL:2019.

However, is there a specified guidance about IFU for 510(k) submission? Which guidance do you use for guiding the requirements of IFU for 510(k) submission?

Any comments by return will be much appreciated!
 

Attachments

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pziemlewicz

Involved In Discussions
#5
There is some IFU info in the Usability / Human Factors guidance.
Additionally, you will provide a copy of your IFU along with that of your predicate in 510(k) submission. In theory, they should be very similar.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#6
FDA just responded to us asking for HFE wrt to IFU. Make sure your reports are robust or Post Market Surveillance can argue the IFU is working.
 
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