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

N

noruskt

Registered
#1
#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?
 
Paper to QMS ad
Elsmar Forum Sponsor
Y

yodon

Staff member
Super Moderator
#2
#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?
 
T

Tidge

Quite Involved in Discussions
#3
#3
I'm sidestepping the direct question about any requirements for usability testing prior to IDE.

noruskt said:
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?
Click to expand...
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.
 
I

indubioush

Quite Involved in Discussions
#4
#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.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
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 0
P Human Factors / Usability validation in the time of COVID Human Factors and Ergonomics in Engineering 14
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
C Stress / Challenge Conditions for Design Verification Testing to Reduce Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
D CFR Title 14: Aeronautics and Space PART 120—DRUG AND ALCOHOL TESTING PROGRAM Federal Aviation Administration (FAA) Standards and Requirements 3
lanley liao Purchase Acceptance Criteria - Tensile testing Oil and Gas Industry Standards and Regulations 2
M Device mounted at IV pole - what about mechanical stability testing? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Outsourcing IEC 60601-1 Ed 3.2 Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
J Cochlear Implant Testing 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Class I (exempt) testing requirements Other Medical Device Related Standards 0

Similar threads

Top Bottom