Medical Device Testing for Airport Security

Aaria

Involved In Discussions
#1
What kind of verification testing can be conducted in order to assess one of the requirements from the draft home use guidance: medical device should be able to pass through airport security screening without malfunctioning?

Any test labs?

Thanks for your input in advance.
 
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N

nomi123

#3
First, you only need to keep such records if you have a procedure which says you need to keep records. As for your auditor, you might ask them to "show you the shall" which states that.

___________
adil
 

Steve Prevette

Deming Disciple
Staff member
Super Moderator
#4
Seems to me you need to find out what methodologies are used as part of airport security screenings, and set up an Operational Test and Evaluation plan to subject the devices to the screenings repeatedly and see how many screenings it takes to cause a "failure". An advantage is you could probably do hundreds of screenings on the device in a fairly short period of time, well exceeding what even the highest frequent flyer would receive in a lifetime.
 

Aaria

Involved In Discussions
#5
Thank you Steve. This is helpful. We will have to look for labs who could simulate screening techniques such as bombard X-ray frequencies etc. So far, I've not been successful finding such a lab.

Best Regards,
Pooja
 
M

MIREGMGR

#6
As for your auditor, you might ask them to "show you the shall" which states that.
This is an FDA sub-forum. "Show me the shall" is a 9001/13485/MDD perspective. In my experience that's a counterproductive approach to take with an FDA inspector. The degree of counterproductiveness will depend on the particular inspector and on FDA's inspection history with your company.

If your most recent prior inspection resulted in a Warning Letter, and particularly if your current visit is a re-inspection or a For Cause inspection, I definitely would not challenge the inspector's interpretation of the rules.

In any case, FDA's "guidances" say "should", but almost always are enforced as "shall".

you only need to keep such records if you have a procedure which says you need to keep records.
Generally, with FDA, it's a good idea to document your conformance approach to every guidance that FDA may conclude applies to you, whether you are happy about its applicability or not.
 
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