Monday, March 27, 2017


Ques: The first question is applicability of usability engineering on all products including legacy.  Do we need to go back and remediate all legacy product files that do not have usability? Is there an expectation to remediate or on a forward moving basis as we make changes to legacy products.

Ans:  I'm not aware of any expectation on the part of the FDA to require such for legacy products until they undergo sufficient change(s) to warrant such (which should be defined in your SOP, as determined by your company's analysis of the usability issues your products pose; and a discussion / rationale written - almost a memo to file or "one page" UE File).  For CE Marking, you'd have to talk to your N-B. 

Ques:  Is the expectation that all devices go through usability? For example for a simple device like a syringe where the risk is well understood and low would we conduct usability? Do you have recommendations for how to proceduralize which products we apply usability to?

Ans:  I would analyze all, even if only to have a UE File that basically says it's not necessary, e.g., your example of the syringe.  Of course if it has some non-stick component, then it would probably require such.  Your company would have to make the decisions as to how to proceduralize / decide which to apply UE to.  In my webinar, I basically stated that some products, like needles (not non-stick), have such a field use history over many decades that they probably wouldn't need it, but that decision / rationale should be defined by SOP and recorded per first ans above.
Ques:   Annex C of IEC 62366-1 has a statement on user interface of unknown provenance, can you explain the intent of this? Is this referring to legacy that does not have usability documentation?

Ans:  As discussed in the webinar, UOUP, applies to user interfaces for which there is no real UE or similar documentation available from a company / vendor.  How it will be specifically applied I don't yet know -- we'll need some field history.  Pending that, I tend to recommend that it be applied for anything posing a serious UE issue for which evidence of any HF / UE activity hasn't been performed / documented.  The principle could apply for a company's own legacy products. Since the analogy to SOUP software was made, how that principle is implements re: software, might help in defining how to implement UOUP.

Ques:  What class devices does usability apply to?

Ans:  There's no specific reference to class of devices, either US or EU.  Obviously, Class II (and IIa, -b) and III would be more complicated, higher risk, and more likely to require  more HF / UE action -- with new major changes, or new devices, a written discussion / rationale appropriate to need / risk, would be appropriate. General controls / cgmps (includes 820.30 where risk mgmt / HF / UE are employed / documented) are also a requirement for Class I in the US, so address as appropriate, defined by your SOP.

John E. Lincoln

Tuesday, March 7, 2017


Some answers to some questions raised on my webinar on the above subject:

Ques: Examples of FDA HF guidance documents, etc?:
As mentioned, use the search box in upper right on FDA web site, as well as links from the above link.

Ques:  HE75?

Ans:  The ANSI web site sells both HE75 and IEC 62366-1:2015 together, and states:
"The ANSI/AAMI HE75 and ANSI/AAMI/IEC 62366 Human Factor Set addresses a broad range of human factors engineering (HFE) topics in a structured format. The material emphasizes adoption of a user-centered focus throughout the product design and development process, with the goal of making medical devices easier to use and less prone to use error. By providing a structured approach to user interface design, this set documents can help manufacturers develop safe and usable medical devices.
  • The ANSI/AAMI HE75 and ANSI/AAMI/IEC 62366 Human Factor Set includes
  • ANSI/AAMI HE75:2009 (R2013) (ANSI/AAMI HE 75:2009 (R2013))
  • ANSI/AAMI/IEC 62366-1:2015"

Not too helpful in my opinion.

The FDA allows you the manufacturer to determine how to address (and they allow plenty of leeway as long as the requirements are addressed by your procedures , and you follow your own procedures).  For CE-marking, work with the preferences of your Notified Body, following the general outline presented in the webinar / standard (the 9 stages, documented in a Usability Engineering File), and and  with consideration of the new EU MDR.

I still believe that the new IEC 62366-1:2015 is the documented process to follow with all current and further UE projects, following and documenting the 9 stages in the UE File as we discussed in the webinar.  The FDA and ANSI/AAMI HE 75 and others could be used in the actual HF/UE analysis where appropriate for ideas, but the documented process should follow IEE 62366-1:2015's 9 stages and the document deliverable in the UE File.

I suspect it will take awhile for some consensus in implementation to build (with the EU implementation).  But I believe that the "end" result will be similar to what I've outlined above. 

-- John E. Lincoln  --