Regulatory Open Forum

Greetings,
In which section of a traditional 510k content should the HFE/Usability studies be discussed? They are not really fitting into the Performance-Bench testing section but I cannot think of anywhere else. I appreciate your input.
Thanks,
Jo

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
------------------------------

Hi Jo:

if you don't think it fits in the bench, animal, or clinical performance sections, you could always put in in section 21 "other". You will also want to ensure information included in your 510(k) summary (briefly) and in your substantial equivalence discussion if relevant. 

Good luck!

------------------------------
Andrea Pilon Artman, MS, CQE
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA
andrea.artman@spectracompliancellc.com
------------------------------

Original Message:
Sent: 21-Jun-2019 11:52
From: Jo Huang
Subject: Human Factors Eng/Usability in 510k submission

Greetings,
In which section of a traditional 510k content should the HFE/Usability studies be discussed? They are not really fitting into the Performance-Bench testing section but I cannot think of anywhere else. I appreciate your input.
Thanks,
Jo

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
------------------------------

If it is not required in the submission, I would not advise submitting, rather just leave it in your design file.  Same with cleaning validation work.  I also know of a company who submits their EU CER in their 510(k) (found it when I requested their 510(k) after they filed a 510(k) statement). Unfortunately for them, they had laid out their whole commercial strategy in it, which I was able to relay to my employer.

Submit adequately for a successful submission, don't oversubmit and leave yourself open to extra questions, delays and competitive discoveries.  By law, FDA is obligated to review everything submitted. 

Good luck!




------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 22-Jun-2019 09:01
From: Andrea Artman
Subject: Human Factors Eng/Usability in 510k submission

Hi Jo:

if you don't think it fits in the bench, animal, or clinical performance sections, you could always put in in section 21 "other". You will also want to ensure information included in your 510(k) summary (briefly) and in your substantial equivalence discussion if relevant.

Good luck!

------------------------------
Andrea Pilon Artman, MS, CQE
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA
andrea.artman@spectracompliancellc.com

Original Message:
Sent: 21-Jun-2019 11:52
From: Jo Huang
Subject: Human Factors Eng/Usability in 510k submission

Greetings,
In which section of a traditional 510k content should the HFE/Usability studies be discussed? They are not really fitting into the Performance-Bench testing section but I cannot think of anywhere else. I appreciate your input.
Thanks,
Jo

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
------------------------------

Hi Jo:

I would be extremely cautious about leaving out material evidence from your 510(k), especially if it was completed to determine that the device functions as intended.  You, or someone in your company, will be signing off on the truthful and accurate statement that no material facts have been omitted.

You can protect yourself from discovery through the FOI process by submitting a 510(k) summary (instead of a statement) and then providing redactions, in the designated timeframe, as requested from FDA. All test reports can be fully redacted. 

Best of luck on this submission!

------------------------------
Andrea Pilon Artman, MS, CQE
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA
andrea.artman@spectracompliancellc.com
------------------------------

Original Message:
Sent: 23-Jun-2019 08:05
From: Ginger Cantor
Subject: Human Factors Eng/Usability in 510k submission

If it is not required in the submission, I would not advise submitting, rather just leave it in your design file.  Same with cleaning validation work.  I also know of a company who submits their EU CER in their 510(k) (found it when I requested their 510(k) after they filed a 510(k) statement). Unfortunately for them, they had laid out their whole commercial strategy in it, which I was able to relay to my employer.

Submit adequately for a successful submission, don't oversubmit and leave yourself open to extra questions, delays and competitive discoveries.  By law, FDA is obligated to review everything submitted.

Good luck!




------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 22-Jun-2019 09:01
From: Andrea Artman
Subject: Human Factors Eng/Usability in 510k submission

Hi Jo:

if you don't think it fits in the bench, animal, or clinical performance sections, you could always put in in section 21 "other". You will also want to ensure information included in your 510(k) summary (briefly) and in your substantial equivalence discussion if relevant.

Good luck!

------------------------------
Andrea Pilon Artman, MS, CQE
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA
andrea.artman@spectracompliancellc.com

Original Message:
Sent: 21-Jun-2019 11:52
From: Jo Huang
Subject: Human Factors Eng/Usability in 510k submission

Greetings,
In which section of a traditional 510k content should the HFE/Usability studies be discussed? They are not really fitting into the Performance-Bench testing section but I cannot think of anywhere else. I appreciate your input.
Thanks,
Jo

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
------------------------------

Thank you both for your insightful suggestions. Deeply appreciated your taking the time to explore the pros and cons of submitting the validation studies such as the HFE!
Sincerely,
Jo

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
United States
------------------------------

Original Message:
Sent: 21-Jun-2019 11:52
From: Jo Huang
Subject: Human Factors Eng/Usability in 510k submission

Greetings,
In which section of a traditional 510k content should the HFE/Usability studies be discussed? They are not really fitting into the Performance-Bench testing section but I cannot think of anywhere else. I appreciate your input.
Thanks,
Jo

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
------------------------------

When I have submitted Usability studies, these have been put in Section 18 - Bench Performance Testing.  This is an appropriate section in my opinion since dealing with validation, usability, engineering type of work and related to performance of the device.  Often usability testing is required by the Agency for products used by lay-person, but yes just make sure according to your device type the Usability study is appropriate to place in the submission.  There is a fine line between providing what is required and what would raise more questions.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 23-Jun-2019 22:40
From: Jo Huang
Subject: Human Factors Eng/Usability in 510k submission

Thank you both for your insightful suggestions. Deeply appreciated your taking the time to explore the pros and cons of submitting the validation studies such as the HFE!
Sincerely,
Jo

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
United States

Original Message:
Sent: 21-Jun-2019 11:52
From: Jo Huang
Subject: Human Factors Eng/Usability in 510k submission

Greetings,
In which section of a traditional 510k content should the HFE/Usability studies be discussed? They are not really fitting into the Performance-Bench testing section but I cannot think of anywhere else. I appreciate your input.
Thanks,
Jo

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
------------------------------

Oh and yes ... never put a Clinical Evaluation Report (CER) written for Europe in a 510(k) submission.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 24-Jun-2019 08:56
From: Richard Vincins
Subject: Human Factors Eng/Usability in 510k submission

When I have submitted Usability studies, these have been put in Section 18 - Bench Performance Testing.  This is an appropriate section in my opinion since dealing with validation, usability, engineering type of work and related to performance of the device.  Often usability testing is required by the Agency for products used by lay-person, but yes just make sure according to your device type the Usability study is appropriate to place in the submission.  There is a fine line between providing what is required and what would raise more questions.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 23-Jun-2019 22:40
From: Jo Huang
Subject: Human Factors Eng/Usability in 510k submission

Thank you both for your insightful suggestions. Deeply appreciated your taking the time to explore the pros and cons of submitting the validation studies such as the HFE!
Sincerely,
Jo

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
United States

Original Message:
Sent: 21-Jun-2019 11:52
From: Jo Huang
Subject: Human Factors Eng/Usability in 510k submission

Greetings,
In which section of a traditional 510k content should the HFE/Usability studies be discussed? They are not really fitting into the Performance-Bench testing section but I cannot think of anywhere else. I appreciate your input.
Thanks,
Jo

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
------------------------------

Thanks, Richard. I was debating on whether or not necessary to include them in the submission. After reading your comments and taking into account some consideration,  I guess I'd walk away from it mainly because the study was not intended to show SE to the predicate, rather, a Marketing approach of user evaluation. My rationale is that validation/feasibility is not on the RTA checklist. If the Agency requests one, I will be glad to supplement it, how does this sound?
Best,
Jo

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
United States
------------------------------

Original Message:
Sent: 24-Jun-2019 08:56
From: Richard Vincins
Subject: Human Factors Eng/Usability in 510k submission

Oh and yes ... never put a Clinical Evaluation Report (CER) written for Europe in a 510(k) submission.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 24-Jun-2019 08:56
From: Richard Vincins
Subject: Human Factors Eng/Usability in 510k submission

When I have submitted Usability studies, these have been put in Section 18 - Bench Performance Testing.  This is an appropriate section in my opinion since dealing with validation, usability, engineering type of work and related to performance of the device.  Often usability testing is required by the Agency for products used by lay-person, but yes just make sure according to your device type the Usability study is appropriate to place in the submission.  There is a fine line between providing what is required and what would raise more questions.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 23-Jun-2019 22:40
From: Jo Huang
Subject: Human Factors Eng/Usability in 510k submission

Thank you both for your insightful suggestions. Deeply appreciated your taking the time to explore the pros and cons of submitting the validation studies such as the HFE!
Sincerely,
Jo

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
United States

Original Message:
Sent: 21-Jun-2019 11:52
From: Jo Huang
Subject: Human Factors Eng/Usability in 510k submission

Greetings,
In which section of a traditional 510k content should the HFE/Usability studies be discussed? They are not really fitting into the Performance-Bench testing section but I cannot think of anywhere else. I appreciate your input.
Thanks,
Jo

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
------------------------------

Just a quick two cents...

I would not rely on what a study was intended to show, but on what the results actually showed.  "Intent" is a regulatory landmine, IMO.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 24-Jun-2019 13:11
From: Jo Huang
Subject: Human Factors Eng/Usability in 510k submission

Thanks, Richard. I was debating on whether or not necessary to include them in the submission. After reading your comments and taking into account some consideration,  I guess I'd walk away from it mainly because the study was not intended to show SE to the predicate, rather, a Marketing approach of user evaluation. My rationale is that validation/feasibility is not on the RTA checklist. If the Agency requests one, I will be glad to supplement it, how does this sound?
Best,
Jo

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
United States

Original Message:
Sent: 24-Jun-2019 08:56
From: Richard Vincins
Subject: Human Factors Eng/Usability in 510k submission

Oh and yes ... never put a Clinical Evaluation Report (CER) written for Europe in a 510(k) submission.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 24-Jun-2019 08:56
From: Richard Vincins
Subject: Human Factors Eng/Usability in 510k submission

When I have submitted Usability studies, these have been put in Section 18 - Bench Performance Testing.  This is an appropriate section in my opinion since dealing with validation, usability, engineering type of work and related to performance of the device.  Often usability testing is required by the Agency for products used by lay-person, but yes just make sure according to your device type the Usability study is appropriate to place in the submission.  There is a fine line between providing what is required and what would raise more questions.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 23-Jun-2019 22:40
From: Jo Huang
Subject: Human Factors Eng/Usability in 510k submission

Thank you both for your insightful suggestions. Deeply appreciated your taking the time to explore the pros and cons of submitting the validation studies such as the HFE!
Sincerely,
Jo

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
United States

Original Message:
Sent: 21-Jun-2019 11:52
From: Jo Huang
Subject: Human Factors Eng/Usability in 510k submission

Greetings,
In which section of a traditional 510k content should the HFE/Usability studies be discussed? They are not really fitting into the Performance-Bench testing section but I cannot think of anywhere else. I appreciate your input.
Thanks,
Jo

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
------------------------------

Hi Jo,

Unless it is required on RTA or in a Special Controls Guidance, I wouldn't submit unless asked.  But have it if requested, and certainly for your Design History File.

Best regards,




------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 24-Jun-2019 13:11
From: Jo Huang
Subject: Human Factors Eng/Usability in 510k submission

Thanks, Richard. I was debating on whether or not necessary to include them in the submission. After reading your comments and taking into account some consideration,  I guess I'd walk away from it mainly because the study was not intended to show SE to the predicate, rather, a Marketing approach of user evaluation. My rationale is that validation/feasibility is not on the RTA checklist. If the Agency requests one, I will be glad to supplement it, how does this sound?
Best,
Jo

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
United States

Original Message:
Sent: 24-Jun-2019 08:56
From: Richard Vincins
Subject: Human Factors Eng/Usability in 510k submission

Oh and yes ... never put a Clinical Evaluation Report (CER) written for Europe in a 510(k) submission.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 24-Jun-2019 08:56
From: Richard Vincins
Subject: Human Factors Eng/Usability in 510k submission

When I have submitted Usability studies, these have been put in Section 18 - Bench Performance Testing.  This is an appropriate section in my opinion since dealing with validation, usability, engineering type of work and related to performance of the device.  Often usability testing is required by the Agency for products used by lay-person, but yes just make sure according to your device type the Usability study is appropriate to place in the submission.  There is a fine line between providing what is required and what would raise more questions.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 23-Jun-2019 22:40
From: Jo Huang
Subject: Human Factors Eng/Usability in 510k submission

Thank you both for your insightful suggestions. Deeply appreciated your taking the time to explore the pros and cons of submitting the validation studies such as the HFE!
Sincerely,
Jo

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
United States

Original Message:
Sent: 21-Jun-2019 11:52
From: Jo Huang
Subject: Human Factors Eng/Usability in 510k submission

Greetings,
In which section of a traditional 510k content should the HFE/Usability studies be discussed? They are not really fitting into the Performance-Bench testing section but I cannot think of anywhere else. I appreciate your input.
Thanks,
Jo

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
------------------------------

If you submit any kind of documentation to a regulatory agency or third-party reviewer, you can be sure they are going to review it, and potentially ask questions about it, whether it was "required" or not.  So if it's not needed, I would keep it at home.

On the other hand, I'd be inclined to think you'd be legally required to include any data that address substantial equivalence, including safety and effectiveness in the event of technological differences, regardless of whether any FDA regulation or guidance specifies them as "required."  But I'm not a lawyer.

Assuming that your HFE/Usability studies collected data from patients/users, I would consider them to be clinical data. (I am having a hard time imagining HFE/Usability being tested on a bench, but I guess stranger things have happened.)   I don't think they are performance data, more like the flip side of that coin, but that's getting into subtleties that probably don't need to be gotten into.  On the other hand, because that's how I see them, I'd probably discuss them separately from Performance/Bench testing.

As for where they "should" be discussed, I would think under the comparison of substantial equivalence, if you are following this guidance for the format and content of a traditional 510(k):

https://www.fda.gov/medical-devices/premarket-notification-510k/how-prepare-traditional-510k#link_4

Note that the guidance makes no reference to "performance," "bench," or "clinical" data.  I think this is appropriate, because I think the inclusion of the data should be driven by the comparisons you need to make to demonstrate substantial equivalence, not where or how the data were collected.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 21-Jun-2019 11:52
From: Jo Huang
Subject: Human Factors Eng/Usability in 510k submission

Greetings,
In which section of a traditional 510k content should the HFE/Usability studies be discussed? They are not really fitting into the Performance-Bench testing section but I cannot think of anywhere else. I appreciate your input.
Thanks,
Jo

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
------------------------------

Dear Ginger and Julie,
I deeply appreciate your thorough explanation. I'm learning more from you than from hands-on experiences!
Respectfully,
Jo

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
United States
------------------------------

Original Message:
Sent: 24-Jun-2019 13:11
From: Julie Omohundro
Subject: Human Factors Eng/Usability in 510k submission

If you submit any kind of documentation to a regulatory agency or third-party reviewer, you can be sure they are going to review it, and potentially ask questions about it, whether it was "required" or not.  So if it's not needed, I would keep it at home.

On the other hand, I'd be inclined to think you'd be legally required to include any data that address substantial equivalence, including safety and effectiveness in the event of technological differences, regardless of whether any FDA regulation or guidance specifies them as "required."  But I'm not a lawyer.

Assuming that your HFE/Usability studies collected data from patients/users, I would consider them to be clinical data. (I am having a hard time imagining HFE/Usability being tested on a bench, but I guess stranger things have happened.)   I don't think they are performance data, more like the flip side of that coin, but that's getting into subtleties that probably don't need to be gotten into.  On the other hand, because that's how I see them, I'd probably discuss them separately from Performance/Bench testing.

As for where they "should" be discussed, I would think under the comparison of substantial equivalence, if you are following this guidance for the format and content of a traditional 510(k):

https://www.fda.gov/medical-devices/premarket-notification-510k/how-prepare-traditional-510k#link_4

Note that the guidance makes no reference to "performance," "bench," or "clinical" data.  I think this is appropriate, because I think the inclusion of the data should be driven by the comparisons you need to make to demonstrate substantial equivalence, not where or how the data were collected.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 21-Jun-2019 11:52
From: Jo Huang
Subject: Human Factors Eng/Usability in 510k submission

Greetings,
In which section of a traditional 510k content should the HFE/Usability studies be discussed? They are not really fitting into the Performance-Bench testing section but I cannot think of anywhere else. I appreciate your input.
Thanks,
Jo

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
------------------------------

So glad to see this discussion thread on this forum. The SF Bay Area Chapter is offering a webinar on Friday, July 26 the Regulatory Requirements and Trends in Human Factors for Medical Device Development. Hope you can join us for this event! I'll also share this discussion thread with our speakers from Outset Medical so they can be sure to touch on this topic as well during the webinar.

------------------------------
Susan Carino, RAC
Principal Consultant, Integrated Project Management Company, Inc.
susan.carino.raps@gmail.com
------------------------------

Original Message:
Sent: 21-Jun-2019 11:52
From: Jo Huang
Subject: Human Factors Eng/Usability in 510k submission

Greetings,
In which section of a traditional 510k content should the HFE/Usability studies be discussed? They are not really fitting into the Performance-Bench testing section but I cannot think of anywhere else. I appreciate your input.
Thanks,
Jo

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
------------------------------

Thank you all who let me know the original link led you to the event announcement but did not allow you to register. Posting a direct link to be able to register for this webinar and earn 1.5 RAC credits for attending.
San Francisco Chapter Webcast: Regulatory Requirements and Trends in Human Factors for Medical Device Development and the User-Device Interface

------------------------------
Susan Carino, RAC
Principal Consultant
Integrated Project Management Company, Inc.
susan.carino.raps@gmail.com
------------------------------

Original Message:
Sent: 26-Jun-2019 13:25
From: Susan Carino
Subject: Human Factors Eng/Usability in 510k submission

So glad to see this discussion thread on this forum. The SF Bay Area Chapter is offering a webinar on Friday, July 26 the Regulatory Requirements and Trends in Human Factors for Medical Device Development. Hope you can join us for this event! I'll also share this discussion thread with our speakers from Outset Medical so they can be sure to touch on this topic as well during the webinar.

------------------------------
Susan Carino, RAC
Principal Consultant, Integrated Project Management Company, Inc.
susan.carino.raps@gmail.com

Original Message:
Sent: 21-Jun-2019 11:52
From: Jo Huang
Subject: Human Factors Eng/Usability in 510k submission

Greetings,
In which section of a traditional 510k content should the HFE/Usability studies be discussed? They are not really fitting into the Performance-Bench testing section but I cannot think of anywhere else. I appreciate your input.
Thanks,
Jo

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
------------------------------

I have a related question and this seems like the right group to answer it.

As far as I can tell, the MDR Technical Documentation does not make any reference to HFE/Usability data.  The MDR itself makes only two references to usability...Article 83 (PMS) and Annex VI Part C (UDI).

Is usability unlikely to be a focus under the MDR, or am I missing something here?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 21-Jun-2019 11:52
From: Jo Huang
Subject: Human Factors Eng/Usability in 510k submission

Greetings,
In which section of a traditional 510k content should the HFE/Usability studies be discussed? They are not really fitting into the Performance-Bench testing section but I cannot think of anywhere else. I appreciate your input.
Thanks,
Jo

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
------------------------------

I'm with you on this Julie. I also get the impression that MDR only mentions the usability in PMS and UDI sections.

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
United States
------------------------------

Original Message:
Sent: 26-Jun-2019 17:16
From: Julie Omohundro
Subject: Human Factors Eng/Usability in 510k submission

I have a related question and this seems like the right group to answer it.

As far as I can tell, the MDR Technical Documentation does not make any reference to HFE/Usability data.  The MDR itself makes only two references to usability...Article 83 (PMS) and Annex VI Part C (UDI).

Is usability unlikely to be a focus under the MDR, or am I missing something here?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 21-Jun-2019 11:52
From: Jo Huang
Subject: Human Factors Eng/Usability in 510k submission

Greetings,
In which section of a traditional 510k content should the HFE/Usability studies be discussed? They are not really fitting into the Performance-Bench testing section but I cannot think of anywhere else. I appreciate your input.
Thanks,
Jo

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
------------------------------

Original Message------

I'm with you on this Julie. I also get the impression that MDR only mentions the usability in PMS and UDI sections.

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
United States
------------------------------

Lee, yes, I was wondering if anyone had expanded, or might eventually expand, on this requirement. 

As it it is written, I wouldn't go so far as to say HFE/usability is in GSPR 5, but that GSPR 5 is a potential path to it, if someone wants to go there.  It's a requirement that doesn't seem to be expected to generate any technical documentation and, as we say, if it's not in writing, it didn't happen.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 27-Jun-2019 06:30
From: Lee Leichter
Subject: Human Factors Eng/Usability in 510k submission

I think it is still in the same place in Annex 1, in GSPR 5; risk related to use.

 

Lee Leichter

President

P/L Biomedical

10882 Stonington Avenue

Fort Myers, FL 33913 USA

Office: +1-239-244-1448

Cell: +1-239-994-6488

Email: leichter@plbiomedical.com

 

Original Message------

I'm with you on this Julie. I also get the impression that MDR only mentions the usability in PMS and UDI sections.

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
United States
------------------------------

In my view, the Human Factors section should be standalone and should follow the section on Safety/Biocompatibility. This is a main focus of FDA's device review, especially but not solely for software. I agree the analysis and the validation testing have to be in the DHF, However, the summary, results and conclusion must also be in the 510k in order to demonstrate the device's use safety and effectiveness in actual use. In fact, FDA Guidance specifically encourages manufacturers to discuss study design in a pre-sub meeting to avoid having to repeat the testing because FDA does not find the methods acceptable.

------------------------------
Jennifer R. Martin
Director - Regulatory Affairs
United States
------------------------------

Original Message:
Sent: 21-Jun-2019 11:52
From: Jo Huang
Subject: Human Factors Eng/Usability in 510k submission

Greetings,
In which section of a traditional 510k content should the HFE/Usability studies be discussed? They are not really fitting into the Performance-Bench testing section but I cannot think of anywhere else. I appreciate your input.
Thanks,
Jo

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
------------------------------