EU Validation Requirement vs. FDA Validation Requirement - EN 62304

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yodon

Staff member
Super Moderator
#13
What I've seen done is that you provide the rationale for not doing a complete re-validation but still do some level of testing. If it makes sense, maybe a reduced PQ or maybe some critical functions from OQ and a reduced PQ. I don't think I've ever seen just a rationalization for not doing any testing.
 
A

Amudha

#15
Hi,

IQ/OQ/PQ applies to product as well, wherein IQ and OQ will be done for equipments used in the manufacturing and PQ applies to the Product Perfromance qualification. AS far as FDA is concerned validations covering IQ/OQ/PQ is required for softwares that are used in testing and designing the medical device or for softwares when itself is used as a component in medical device.

Hope this helps.
Thx
Amudha
 

sagai

Quite Involved in Discussions
#17
Watchwait
... your case is a good example of why they created this abbreviated path! Good Luck!
In FY2008 for 510k:
2572 traditional submission
138 abbreviated submission
653 special submission
reached the FDA's ODE.

see more:
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm109772.htm

I think abbreviated 510k is only a path for very very confident companies, due to the not only general and special controls (for ClassII) shall be implemented, but applicant shall submit conformance statement for other recognized standards, and its a really really hard to be fully conform with those on a real operational level.



Asherlee
...From my experience with the FDA, when they publish a Guidance Document that is applicable to your situation, then you should carry out the recommendations contained in the Guidance Document as much as possible/applicable.
The Guidances are the Special Controls themselves and those are mandatory for Class II devices, for Class I only General Controls shall be applied.
There are several Guidances, and I am pretty not sure everybody knows them, furthermore there are more according to product types/codes, especially for ivd devices.



"
Watchwait
... the change has no impact on the functionality of the application and no revalidation is necessary based on the documentation provided."
There is always a reason behind the change.
I do not think it can be simple rationalized, because the change itself, even if you do not use that specific function, can result side-effect on your used functionality.
Rational is great to describe the reason you do not perform full verification/validation, but surely there is a verification effect on every change.

br
Sz.
 
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