SBS - The best value in QMS software

Usability testing required for FDA IDE (investigational device exemption)?

#1
What is the general thinking about the requirement of usability testing prior to the submission of an FDA IDE? Is FDA requiring it? It seems to me that we should be able to justify using pre-clinical data that the clinical trial will be used to support usability, as long as usability is evaluated during the trial. Right?
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
I don't think I've seen any specific requirements imposed. You may need to provide assurance that potential use / usability errors won't lead to harm. Consider doing a task analysis or PFMEA and consider missteps / errors and results. Maybe training is warranted or oversight?
 

Tidge

Trusted Information Resource
#3
I'm sidestepping the direct question about any requirements for usability testing prior to IDE.

It seems to me that we should be able to justify using pre-clinical data that the clinical trial will be used to support usability, as long as usability is evaluated during the trial. Right?
As far as I know, this is still applicable : Applying Human Factors and Usability Engineering to Medical Devices

Relying on the IDE is probably not the same as considering 'simulated use', but the underlying concerns are roughly the same. Without knowing any details about the device, the IDE or specific usability concerns I will write this: I have a general expectation that the IDE will be able to inform elements of the usability assessment of the final product. A priori I don't expect the IDE work to completely replace the efforts during validation.
 

indubioush

Quite Involved in Discussions
#4
Usability testing should be performed early in device development. Formative evaluations can result in design changes to reduce use error. Much easier to change the design prior to the validation stage. Regulating bodies have been a bit lenient when it comes to usability, but that may change.
 
#5
Responding here since I have the same question but I'm not totally sure it was answered - I am in a similar situation where I am trying to figure out the requirements prior to IDE. I certainly intend to do risk analysis, defining users and use environment and perhaps some preliminary formative work, but I am not sure what (if anything) we would need to submit or have ready on file before an IDE submission. But in reading this:

You may need to provide assurance that potential use / usability errors won't lead to harm.
I'm curious how you would do that without a full summative study, which in my experience is not done before early clinical work (we won't have a truly final design from a commercial perspective during the first trial).

Any thoughts? Not looking to wiggle out of HF work but I just don't see anything to go from in the HF or IDE guidances.
 

yodon

Staff member
Super Moderator
#6
I'm curious how you would do that without a full summative study
Your risk analysis needs to provide guidance here.

Also, for electro-mechanical systems, we generally have some degree of 60601-1 testing done prior to the study to give some assurance of basic safety.
 
#7
Also, for electro-mechanical systems, we generally have some degree of 60601-1 testing done prior to the study to give some assurance of basic safety.
This has definitely come up in my conversations as well, and questions like "can we list compliance to 62366" but that would require a full summative study on file, no?

The risk analysis is in progress and will definitely be helpful as well, but I can already assure there will be some critical tasks. I'm hoping to evaluate them in a formative soon but with whatever issues come up I'm not sure to what degree we need to resolve them before the IDE.
 

Tidge

Trusted Information Resource
#8
... and questions like "can we list compliance to 62366" ...
I wouldn't say that a product is 'compliant with 62366 (or 62366-X)' any more than I would say a piece of ME software is 'compliant with 62304'. You can self-advertise that you applied the principles of 62366, but 'compliance' is going to demonstrated by the applicable standard (for ME devices, it is 60601-1).

I don't want to speak for @yodon but I think the point he is making immediately above is that for a somewhat new device there are well-known hazards to which you wouldn't want to expose patients/users before even planning any sort of clinical study. Things like shocks, sharps, burns, pinches were included in the scope of the second edition of 60601-1 and were recognized as 'needing to be controlled/eliminated' independent of a 'modern' 60601-1 compliance assessment that includes risk analysis of a ME device taking Essential Performance (including usability) into account.
 
Thread starter Similar threads Forum Replies Date
Q Summative Usability Evaluation Testing: prior or during Clinical Investigation? Human Factors and Ergonomics in Engineering 6
M Informational Understanding Costs And Risks For HFE Usability Studies — Part 1: Testing In-House Medical Device and FDA Regulations and Standards News 0
V 510(k) vs. CE Marking Summative Usability Testing Expectations IEC 62366 - Medical Device Usability Engineering 4
K Usability for custom made medical devices IEC 62366 - Medical Device Usability Engineering 5
P Human Factors / Usability validation in the time of COVID Human Factors and Ergonomics in Engineering 17
V Applicability of IEC 62366-1 usability to resorbable bone substitutes IEC 62366 - Medical Device Usability Engineering 9
pashah Looking for Usability File Template acc. IEC 62366-1 and IEC 60601-1-6 IEC 62366 - Medical Device Usability Engineering 4
C Usability IEC 62366-1:2015 and MDR 2017/745 - Risk based approach IEC 62366 - Medical Device Usability Engineering 1
T MDR article 22 - System of 2 CE products and validation / usability? EU Medical Device Regulations 10
P Usability/human factors engineering requirement (standard) for IVD medical device Other Medical Device Related Standards 2
P Global medical device human factors/usability requirement IEC 62366 - Medical Device Usability Engineering 3
E Usability Process - Looking for a template (IEC 62366) IEC 62366 - Medical Device Usability Engineering 1
S Usability procedure - looking for a template IEC 62366 - Medical Device Usability Engineering 3
K Usability of ME Equipment - IEC-62366-1:2015 IEC 62366 - Medical Device Usability Engineering 3
M Usability Standard - The difference between IEC 60601-1-6 to IEC 62336 Human Factors and Ergonomics in Engineering 1
M IEC 62366-1:2015 Usability Verification / Validation Plan example wanted IEC 62366 - Medical Device Usability Engineering 20
Q EU ROHS and GUI Usability Trial Requirements EU Medical Device Regulations 10
M New MHRA guidance on Human Factors - Usability Engineering IEC 62366 - Medical Device Usability Engineering 1
S IEC 62366 - Usability Test Protocol format Imported Legacy Blogs 0
M Does Medical Device Usability Study = Clinical Trial? Other Medical Device and Orthopedic Related Topics 26
L BSI White Paper on Human Factors/Usability Engineering IEC 62366 - Medical Device Usability Engineering 12
R What is the typical industry standard for documenting Usability Risk? Human Factors and Ergonomics in Engineering 16
F Usability Objectives and Verification & Validation Plan IEC 62366 - Medical Device Usability Engineering 6
Z IEC 62366 and Medical Device Usability Validation IEC 62366 - Medical Device Usability Engineering 10
P Number of Participants - Usability Validation IEC 62366 - Medical Device Usability Engineering 3
C Application of IEC 62366 - Usability of Non-Active Medical Devices IEC 62366 - Medical Device Usability Engineering 15
P Usability Plan for Existing Equipment IEC 62366 - Medical Device Usability Engineering 5
Ronen E Can Usability Studies save lives? Other Medical Device and Orthopedic Related Topics 1
L Patient Monitor Viewing Distance Usability Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
M IEC 62366:2007 - Is FDA Usability Engineering Standard a Requirement in Canada? Canada Medical Device Regulations 5
S IEC 62366 - Embedded Software in separate Usability Engineering File? IEC 62366 - Medical Device Usability Engineering 1
S IEC 62366 for Stand-Alone Medical Device Software and Usability Engineering IEC 62366 - Medical Device Usability Engineering 16
D Training on IEC 62366 (Medical Device Usability Engineering) for CE Mark? IEC 62366 - Medical Device Usability Engineering 5
Y Applying Human Factors and Usability Engineering - FDA Guidance Document 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S New Draft FDA Guidance - Human Factors & Usability Engineering for Med Device Design US Food and Drug Administration (FDA) 0
C Understanding Design Decisions relating to Safety and Usability Human Factors and Ergonomics in Engineering 3
M Employees Awareness, Usability & Effectiveness of the ISO QMS - Survey needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
D IEC EN 62366 Usability Retroactive Compliance Other Medical Device Related Standards 1
N Usability Formula to Predict Use Error Reduction IEC 62366 - Medical Device Usability Engineering 6
R ISO IEC EN 62366 Usability Engineering Essential Requirements IEC 62366 - Medical Device Usability Engineering 8
M Link between Risk Management, Usability Engineering and R&D in Medical Devices ISO 14971 - Medical Device Risk Management 2
W Usability Engineering ISO 62366:2008 - Medical Devices IEC 62366 - Medical Device Usability Engineering 124
C Usability Engineering File - Looking for an example/template IEC 62366 - Medical Device Usability Engineering 3
S Usability standard IEC 60601-1-6 in the Medical Device Industry IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
E 60601-1 - Tilt testing - Tensile safety factor IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
V Setup for testing against ISO14708 clause 16 (protection of the patient from herms caused by heat) Other Medical Device Related Standards 0
gramps What do you think about automated QA testing For software app industry? Misc. Quality Assurance and Business Systems Related Topics 5
B In house NIOSH pre Testing accepted by NIOSH? US Food and Drug Administration (FDA) 1
M Bacteriostasis/Fungistasis Testing Other Medical Device and Orthopedic Related Topics 6
P Sample Size for Distribution Simulation Testing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11

Similar threads

Top Bottom