Hello!
I came to the community seeking similar information as the original poster. I have some follow up questions for those with modular PMA experience. I appreciate your comments on my current understanding.
It seems to me that the potential benefit of a modular approach is in clearing deficiencies earlier in the process and therefore de-risking the approval within 180 days of the final module submission. This benefit may be lost if there are changes to design or manufacturing between submission of the first and last module.
For a development team that is planning design changes compared to the IDE version of the device, the modular approach may not be appropriate. In the situation I'm considering, the development team is currently planning to finalize their work in a "finish-to-finish" alignment with the clinical data readiness. Since modular PMAs require 90-day periods for each module, this wouldn't be an option with the current development plans. Is this correct?
Instead, the design would need to be frozen well in advance of the clinical data availability since it is a linear flow: 90 days for Module 1 + 90 days for Module 2, etc. 90 days minimum for each. So if you have a total of 4 modules with clinical last, then you need to submit Module 1 at least 9 months in advance. Probably much more in reality.
Is there a way to identify modular vs. non-modular PMA's in the FDA database? Or any other publicly available data on whether the modular approach has demonstrated timeline advantages?
Thanks for sharing your experience and expertise!
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Marianne Jacklyn
Principal Consultant
West Linn OR
United States
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Original Message:
Sent: 20-Jan-2021 08:16
From: Ted Heise
Subject: Modular PMAs vs. traditional PMAs
Hi Anon,
Completely agree with Richard's comments on modular PMAs. We've done a number of them at MED Institute, and they work quite well--if the timing is appropriate.
The first step is to lay out a proposed organization and schedule for the modules, and confirm that it's possible to gain some efficiency with this approach. Consider too that FDA may not accept a modular submission if there is not enough separation between modules that will process through some of the same FDA team members. They want to gain efficiency too, and there may be little to gain (or even a net loss) if there is too much overlap.
Recognize that the data for some of the modules (especially non-clinical testing, animal studies, and biocompatibility) will have been largely completed for the IDE, so should be available for PMA submission well ahead of the pivotal clinical study data.
Regarding the risk of device changes, it's very hard to offer any suggestions without knowing details of the technology and the clinical study design. Happy to discuss if you wish to contact me directly.
Hope this is helpful!
Best regards,
Ted
--
Theodore (Ted) Heise, PHD, RAC
Vice President Regulatory and Clinical Services
MED Institute Inc.
1330 Win Hentschel Blvd.
West Lafayette, IN 47906-4149 USA
765.463.1633 ext. 4444
http://medinstitute.com
theise@medinstitute.com
Original Message:
Sent: 1/20/2021 5:11:00 AM
From: Richard Vincins
Subject: RE: Modular PMAs vs. traditional PMAs
Hello Anon,
First, yes there is significant backlog at FDA - refer to lots of other posts.
In working with Modular versus traditional PMA for my experience in working with both is mainly about timing. If your development and study process is a long period of time, Modular might work better because you can submit the Modules when ready. If the clinical study is almost finishing and have had discussions with FDA during pre-IDE meetings or other Q-Submission meetings, than a traditional may be a good way. In essence, it is about submitting the Modules when ready versus submitting everything all at the same time. Previous years, I had good response turnaround from FDA on Modular PMA, so again if your development and getting to market is stretched over a longer period of time this might be a viable option.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 15-Jan-2021 20:30
From: Anonymous Member
Subject: Modular PMAs vs. traditional PMAs
This message was posted by a user wishing to remain anonymous
Hi all,
I've read all the PMA guidances I can find and have a good handle on those.
What I am wondering is - what have people's real life experiences been with modular PMAs? We had one consultant not recommend them in the past, saying that the expectations didn't align with our product development schedule. On paper, modular PMAs seem like they would be helpful to get certain modules submitted while the clinical trial is ongoing, but what makes me nervous is if things change during the course of the trial and we need to resubmit parts of already closed modules due to that.
What do you think, RAPS forum? Does FDA get back within 90 days per module? Is needing to change something within a previously closed module a common occurrence? Is the modular PMA worth it?
Also, if there are any changes in FDA responses due to Covid backlogs, would appreciate any input on that too.
Thanks!
Anon.