EU Validation Requirement vs. FDA Validation Requirement - EN 62304

[Hrobot]

Dear all,

Our software development SOP (for a class 2 medical device with an embedded software) is based on EN 62304. I am now trying to submit a 510(k) and realised that the terminology for software testing requirement has changed from Unit Testing and verification/System testing to IQ/OQ/PQ (Installation/Operational/Performance Qualification).
Do we have to change our terminology documentation format to fulfill FDA's requirement?

The same goes to the final device functionality test protocol. Whilst this is fine for MDD do I need to create an IQ/OQ/PQ protocol for the US market?

Your advice will be greatly appreciated

H

[Ajit Basrur]

Did you have a look at IEC 62304:2006 ? This is recognized by FDA.

[harry]

In Reply to Parent Post by Hrobot

Dear all,

Our software development SOP (for a class 2 medical device with an embedded software) is based on EN 62304. I am now trying to submit a 510(k) and realised that the terminology for software testing requirement has changed from Unit Testing and verification/System testing to IQ/OQ/PQ (Installation/Operational/Performance Qualification). ........

Somebody correct me if I am wrong. Unit testing applies to software - unit testing is a procedure used to validate that individual units of source code are working properly whereas IQ/OQ/PQ refers to the need to validate the complete equipment or machine at the relevant stages suggested by the term itself.

[Hrobot]

I think I made a mistake there to reference unit testing where I should have just referred to the final system testing.

I have checked the standards which are recognised by FDA and it includes 62304 Software life cycle, 60601 medical electronic equipment and 14971 risk management which are all the standards that we adhere to.

DOes this mean that I could use the Abrreviated 510(k) with a declaration of conformity to these standards?

regards,
H

[Watchwait]

I just went back through and read both the FDA 510(k) new Paradigm and the requirements for using an Abbreviated 510(k). Sounds like your case is a good example of why they created this abbreviated path! Good Luck!

[Watchwait]

I am also very interested in the interpretation of the IQ/OQ/PQ comment in HROBOTs first posting. Is the implication that if these particular terms are not mentioned in IEC 62304 that they are not required by FDA? I'm far from a software expert, hence my naivete/curiosity.

[yodon]

In Reply to Parent Post by Watchwait

I am also very interested in the interpretation of the IQ/OQ/PQ comment in HROBOTs first posting. Is the implication that if these particular terms are not mentioned in IEC 62304 that they are not required by FDA? I'm far from a software expert, hence my naivete/curiosity.

There is nothing in 21 CFR 820 (regulation by which FDA requires compliance for device development and manufacturing) that requires a particular test paradigm for product verification and validation.

In my experience, IQ/OQ/PQ are typically (only) used in manufacturing equipment validation, not product V&V.

[Asherlee]

I recently submitted a 510(k) for a medical device with embedded SW. I based my SW documentation and terminology on the outlines described in the FDA Guidance document entitled:" Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005".

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.

Note that if you submit Declarations of Conformity in lieu of actual test reports, then they should comply with the FDA requirements listed in the attached table.

Also, the FDA has several Guidance Documents on the Use of Standards in Substantial Equivalence Determinations.

Regards,

Asherlee