IEC 62304, ISO 14971 and FDA Medical Device SW Guidance

mscottf

Scott Fine
The main FDA Guidance for medical device software development is Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005). This predates ISO 14971:2007 and IEC 62304:2006.

Both of these have been amended, however the 2012 amendment to ISO 14971 has not been recognized by the FDA as a consensus standard and it is also not recognized in the 2015 amendment to IEC 62304.

Yet, our SW contractor recommends making our Quality documentation compliant with ISO 14971:2012 Annex ZA, including the concept of reducing risk AFAP instead of ALARP, and not using labeling and training as risk control measures.

Would you agree with this strategy? It could be much more costly and time-consuming.

Do you know when an update to the FDA Guidance may occur?

Do you know when the release of IEC 82304 (for stand-alone software) is expected?

Thanks.
 

yodon

Leader
Super Moderator
I think the FDA does recognize 62304:2016. Go to this link and search on 62304: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

Back to your other questions...

14971:2012 - point of clarification, you can't use labeling to reduce the risk but labeling is still indicated for risks. Yes, certainly more effort to mitigate AFAP. I believe that even though not a consensus standard, the FDA would accept Risk Management compliant with :2012. You'd be "managing more" (ostensibly a safer product) not "managing less." So if you're planning on going to the EU, maybe it's a good strategy. (And really, how effective is controlling risks through labeling??)

I've not heard of any plans for the FDA to update the guidance. Seems the focus there is on post-market things. I don't have any inside info so no help there.

Also no idea about an 82304 release date.
 

Marcelo

Inactive Registered Visitor
Both of these have been amended, however the 2012 amendment to ISO 14971 has not been recognized by the FDA as a consensus standard and it is also not recognized in the 2015 amendment to IEC 62304.

FDA does not recognize ISO 14971:2012 because it does not exist. What exists is the 2012 European version of ISO 14971:2007, EN ISO 14971:2012. FDA only recognize US or international standards.

Do you know when an update to the FDA Guidance may occur?

I don't see any information regarding any revision. I'm not sure there's a need for it, either.

Do you know when the release of IEC 82304 (for stand-alone software) is expected?

Next year.
 

mihzago

Trusted Information Resource
On the one hand I would agree with the consultant's recommendation, because as yodon said, labeling and training are often not very effective; however, the Annex ZA of EN/ISO 14971 does not say you cannot use these types of controls to reduce risk. The deviation #7 in the Annex says that "manufacturers shall not attribute any additional risk reduction (...) to the "information for safety"", which is not the same as using instructions for use to reduce risk.


See the recommendation by the Notified Body Recommendation Group in the consensus paper titled: "Consensus Paper for the Interpretation and Application of Annexes Z in EN ISO 14971: 2012"

Recommendation:
Any information for safety comprising instructions of what actions the user can take or avoid in order to prevent a hazardous situation from occurring may be considered a risk control measure. As required by Essential Requirement 13.1 of Directive 93/42/EEC (respectively ER B.8 of 98/79/EC) it may be considered as a risk control measure. The information includes the instructions for use, labels, etc.. Since ‘safe use’ is related to risk control measures, the Medical Device Directives do not deviate
in that regard from EN ISO 14971. Any effects on risk reduction are to be documented by the manufacturer in the risk management file.
‘Disclosure of residual risk’ should be conducted in compliance with EN ISO 14971 Clause 6.4, 6.5 and 7. The manufacturer shall not claim a reduction to the probability of harm when disclosing residual risk.
Compliance is checked by inspection of the risk management file.
 

mscottf

Scott Fine
Thank you all for your responses.

My reason for asking about an update to the FDA Guidance is because it predates SmartPhone technology (Apps and APIs) and there is no mention of software relative to connecting to the "cloud" in order to update medical data.

The FDA Guidance - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (COTS) Software (2005) addresses security issues only, not development issues.

The FDA Guidance - Off-The-Shelf Software Use in Medical Devices (1999) is even older. Should it just be assumed that all such software would be fully covered according to this guidance?

Thanks.
 

mihzago

Trusted Information Resource
The FDA guidance documents you listed do not describe the development process. Since all design and development, regardless of the type of the product and its features must follow Design Controls, the "Design Control Guidance" would be more appropriate. To your point, however, many of these guidance document don't have a lot of examples specific to software, and are written in traditional "manufacturing" language, which is often obscure to software developers, so a good bit of interpretation is required.

The regulation and guidance is generic enough that it applies to all types of devices. If you combine the Design Control Guidance, with the other guidance documents, and IEC 62304 and ISO14971, and supplement with other Consensus Standards such as: TIR45, IEC80001 series (see a full list here: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm), that should give you sufficient info.

There is another guidance that may be useful: "Postmarket Management of Cybersecurity in Medical Devices"

Oh and I almost forgot one more, specific to software that was just released last week. "Deciding When to Submit a 510(k) for a Software Change to an Existing Device", which contains many examples that should give you an idea what the agency is looking for in terms of documentation.
 
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