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

[Ashley Fu]

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!

 

[monoj mon]

However, is there a specified guidance about IFU for 510(k) submission?

to my knowledge, there is no such specific guidance. You can get some hints here. Additionally, just keep in mind that, the "Intended Use" statement must be identical everywhere.

 

[Ashley Fu]

to my knowledge, there is no such specific guidance. You can get some hints here. Additionally, just keep in mind that, the "Intended Use" statement must be identical everywhere.

It seems the basic source comes from 21 CRF Patrt 801.

CFR - Code of Federal Regulations Title 21

 

[monoj mon]

It seems the basic source comes from 21 CRF Patrt 801.

CFR - Code of Federal Regulations Title 21

Yes.

 

[pziemlewicz]

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]

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.