Do I need test reports for all standards mentioned in my 510k application?

EMC_noob

Starting to get Involved
#1
Dear experienced medtech developers,
In 510k summaries like K182768 (sorry, I'm not allowed to post links), you will find a sentence like "[the subject device] was tested to the following standards: 1) 60601-1 and 2) 60601-1-2. Later in the application (in this case under Performance Data, p. 7),the manufacturer mentions that they have done functional tests in accordance with 62366 (usability) and that their software is validated in accordance with 62304.

Does this mean that the manufacturer have undergone testing with a testing facility to produce test reports for 60601-1 and 60601-1-2 only, and that they simply comply with parts of the two other standards (62366 and 62304) and do not have test reports for those "extra" standards? Or put in a different way: Can I get away with brining up standards in my application without having to comply with all of them i.e. get a test reports for everything?

Hope it makes sense

Thank you!
 
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Tidge

Trusted Information Resource
#2
I am very comfortable in writing: 62304 is a process standard, there wouldn't be a meaningful certification from any external body. Depending on the Level of Concern (roughly commensurate with 62304 Software System Safety Classification), the 510(k) submission will have to submit specific artifacts. These required elements of the submission align with 62304 artifacts. The agency expects to see them, they wouldn't accept a "certification" that you happened to have them (but aren't sharing them) for a device anyway.

When it comes to Usability, I believe it is possible to have testing done that is motivated by the discrete parts of those standards (62366-1 and 62366-2) but as with software development a "certification" wouldn't really mean much.

The "compliance with" standards 62304, 62366ff would be demonstrated by specific artifacts in the submission and not some external certification.
 

yodon

Leader
Super Moderator
#3
That's a tough one. I've had mixed experiences.

Because 14971 calls out 62304 and 62366, a 'normal' 60601-1 assessment by a lab will include both a software lifecycle review (compliance to 62304) and a usability engineering assessment (compliance to 62366). If included, the test lab will issue a report concluding (presumably) that compliance to those standards was demonstrated. You can opt out of those assessments.

I've seen FDA accept a manufacturer's assertion of compliance with the standards with no real supporting data or additional review. I've had NB reviewers say that either I get a test lab report OR they would do a comprehensive review (at about 2x the cost of the original review quote). So to @Tidge 's point about a meaningful certification, certainly the NB would accept the conclusions from an accredited lab. Again, that's my experience and so we always opt for the lab to do the assessments. That's the smoothest path for our clients.
 

mihzago

Trusted Information Resource
#4
For the FDA submission you don't need a test lab report for 62304/62366. Neither standard has testable requirements, and FDA will review your software and usability documentation anyway.

For NB review, I've heard from several people (there was also a thread here recently on this topic) that NBs ask for a certification or will add review time.
 

EMC_noob

Starting to get Involved
#5
Thank you all for your swift and thorough replies! That was exactly what I needed to move on with our application writing

Cheers
 

Tidge

Trusted Information Resource
#6
This is just my opinion, based on working with NRTLs on 60601-1 testing: I put no value in a NRTL's assessment of 'compliance' to standards like 14971, 62304 or 62366. Some aspects of each is covered in the checklists for 60601-1 certification, but generally the NRTLs don't have folks with enough experience to recognize or evaluate the purpose of development standards like those. This is NOT to say that (some) NRTLs DON'T have some folks on site available to do "PEMS Assessments" (if they still refer to them this way) that can be tapped for some elements of software assessments... it's just that the folks at NRTLs aren't going to be particularly engaging partners when it comes to how a medical device design team uses (or abuses) 14971, 62304 or 62366.

I don't completely fault NRTLs on this point: By (business) design, they have to be focused on repeatable testing... but I got the sense that the third edition of 60601-1, specifically the 'revelation' that Risk Management is actually the source of something like Basic Safety, was greeted with both skepticism ("We know how to test for Safety") and snark ("So tell me about your Essential Performance, what tests do you think we should perform?"). Another mitigating factor for why I personally don't expect anything like 'excellence' from a NRTL with respect to process standards: every device designer has the freedom to develop their own processes, so given the possible variety it would be a waste of time for NRTLs to try to understand any of them.
 

EMC_noob

Starting to get Involved
#7
This is just my opinion, based on working with NRTLs on 60601-1 testing: I put no value in a NRTL's assessment of 'compliance' to standards like 14971, 62304 or 62366. Some aspects of each is covered in the checklists for 60601-1 certification, but generally the NRTLs don't have folks with enough experience to recognize or evaluate the purpose of development standards like those. This is NOT to say that (some) NRTLs DON'T have some folks on site available to do "PEMS Assessments" (if they still refer to them this way) that can be tapped for some elements of software assessments... it's just that the folks at NRTLs aren't going to be particularly engaging partners when it comes to how a medical device design team uses (or abuses) 14971, 62304 or 62366.

I don't completely fault NRTLs on this point: By (business) design, they have to be focused on repeatable testing... but I got the sense that the third edition of 60601-1, specifically the 'revelation' that Risk Management is actually the source of something like Basic Safety, was greeted with both skepticism ("We know how to test for Safety") and snark ("So tell me about your Essential Performance, what tests do you think we should perform?"). Another mitigating factor for why I personally don't expect anything like 'excellence' from a NRTL with respect to process standards: every device designer has the freedom to develop their own processes, so given the possible variety it would be a waste of time for NRTLs to try to understand any of them.
Excellent points, Tidge! After having had my first real encounter with the test labs in assessing our 60601-1 procedures, I also found that they didn't have sufficient experience with software in order to critically review the SW parts of our documentation, and that they suggested hardware solutions whenever the software was deemed high risk.
 

Tidge

Trusted Information Resource
#8
Thanks for sharing your experience.

I also found that they didn't have sufficient experience with software in order to critically review the SW parts of our documentation, and that they suggested hardware solutions whenever the software was deemed high risk.
I wouldn't be surprised if this was exactly what the NRTL said, but even if the remark isn't precise, it is indicative of why I shake my head at certain NRTL interactions. Software isn't a Hazard (at least not until we are completely robotic), and the (medical) risk associated with software is derived completely from the nature of the functions allocated to the software, so it is rather presumptuous of a NRTL to propose alternate technological solution, i.e. "don't use software", just because the developer has done a thorough risk analysis.

As I wrote above: I don't hold NRTLs in contempt for this sort of ignorance. I do think that NRTLs should be more understanding and less rigid when it comes to their interaction with manufacturers when it comes to process standards like 14971, 62304 and 62366. I completely understand that decades of manufacturers rationalizing (prior 3rd edition) why a device ought to be able to skirt the requirements of 2nd edition has made the NRTLs peculiarly stubborn... I just want them to be more open about the different between safety requirements of a standard and the development process that leads to safe devices.

Many years ago it looked like one of the major NRTL was moving in a direction where they would have a separate individual (distinct from the 'test team') explicitly to act as the receptacle and processor for the process-related documents that get provided as part of that NRTL's generic '60601-1 checklist'.. my understanding was that this individual (and it was essentially a single person) was going to act as the filter between the 'test guru' and the manufacturer to make sure that the test guru was asking meaningful questions (that didn't already have answers in the process required documentation, such as within risk assessments) and could make sure that the manufacturer understood the specific nature of questions (with the necessary tie to the standards under consideration). I don't know what became of that initiative, as my last interaction with the NRTL involved no small amount of training their 'test team' to several different process standards. We literally had to write memo after memo for them where we quoted little more than the just standards' text and the informative annexes.
 

EMC_noob

Starting to get Involved
#9
Thanks for sharing your experience.
Likewise! We are a small startup engaging with this process for the first time more or less. Although having accepted that we are pretty much at the mercy of the test labs, it is a bit frustrating to have the feeling that our test outcome would have been drastically more different if the testers were a bit more code savvy. Oh well, we'll find a way through it!

Thanks again
 
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