Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Our FDA reviewer said we need to have minimum of 90 days between 2 PMA modules. However, we would like to submit 2 modules in 60 days.
Is there any FDA regulation or guidance which mandates manufacturer's to submit 2 modules with a minimum of 90 days of interval? 

Would appreciate input from the community.

Well, the guidance below doesn’t explicitly say that modules need to be submitted 90 days apart. However, it does say that:

a) FDA wants to allow enough time to review each module, and,
b) FDA expects to issue a decision on each module within 90 days.

Basically, the modular PMA program is designed to allow a staggered (or modular) submission. FDA’s stance is that if you are able to submit your modules with less than 90 days between each module, then you would probably opt for a traditional PMA submission. Taken together, it makes sense why your reviewer told you that you need 90 days between each module submission. FDA wants to be able to close out a module before moving on to reviewing the next module.

FDA does note that the manufacturing module can be submitted concurrently with any other module. So if one of your two modules that you’d like to submit 60 days apart is manufacturing, then you are good to go.

https://www.fda.gov/media/73513/download

---------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA
---------------------------------



Original Message:
Sent: 26-Oct-2021
From: Anonymous Member
Subject: Time between 2 PMA modules (90 days?)

This message was posted by a user wishing to remain anonymous

Our FDA reviewer said we need to have minimum of 90 days between 2 PMA modules. However, we would like to submit 2 modules in 60 days.
Is there any FDA regulation or guidance which mandates manufacturer's to submit 2 modules with a minimum of 90 days of interval? 

Would appreciate input from the community.

Hello Anon,

Agree with Hiral the guidance doesn't specifically say, but indeed some of the Modules can be submitted in a shorter time frame, or even concurrently depending on the module like Module 3.  This is usually dependent on the reviewer, their current work load, and what type of device they are reviewing.  At the beginning you will also have your PMA Shell reviewed which I would highly recommend including timelines for when these would be available.  As an example, Module 1 - 3 may be right in a row, but the clinical trial is going on for a much longer period of time for the Final Module may take more time.  Also make sure to anticipate any deficiencies identified in the module as well as this takes time to address, so if you commit to a strong 90 days between modules and Module 2 takes 120 days because of questions on testing, this can have an impact on the review of the other modules.  The whole idea with a Modular PMA is it gives both the reviewer and the company time to "review together" instead of a Traditional PMA being submitted all at one time.

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

Original Message:
Sent: 26-Oct-2021 22:19
From: Hiral Dutia
Subject: Time between 2 PMA modules (90 days?)

Well, the guidance below doesn't explicitly say that modules need to be submitted 90 days apart. However, it does say that:

a) FDA wants to allow enough time to review each module, and,
b) FDA expects to issue a decision on each module within 90 days.

Basically, the modular PMA program is designed to allow a staggered (or modular) submission. FDA's stance is that if you are able to submit your modules with less than 90 days between each module, then you would probably opt for a traditional PMA submission. Taken together, it makes sense why your reviewer told you that you need 90 days between each module submission. FDA wants to be able to close out a module before moving on to reviewing the next module.

FDA does note that the manufacturing module can be submitted concurrently with any other module. So if one of your two modules that you'd like to submit 60 days apart is manufacturing, then you are good to go.

https://www.fda.gov/media/73513/download

---------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA

Original Message:
Sent: 26-Oct-2021
From: Anonymous Member
Subject: Time between 2 PMA modules (90 days?)

This message was posted by a user wishing to remain anonymous

Our FDA reviewer said we need to have minimum of 90 days between 2 PMA modules. However, we would like to submit 2 modules in 60 days.
Is there any FDA regulation or guidance which mandates manufacturer's to submit 2 modules with a minimum of 90 days of interval?

Would appreciate input from the community.

I have filed a Modular PMA (3 Modules) where I filed Modules 1 +2 one month apart and the last 2 months after. This has to be negotiated with FDA during construction of the Modular Shell. Our agreed upon Shell was officially sent to FDA 2 weeks before sending Module 1.

If your review Division is telling you 90 days, you can try and push back but its likely due to resources on their end. I have never re-negotiated with FDA to modify the Shell but that might be something to explore, particularly if some module review is quicker than anticipated.

------------------------------
John DeLucia
Consultant
------------------------------

Original Message:
Sent: 26-Oct-2021 22:19
From: Hiral Dutia
Subject: Time between 2 PMA modules (90 days?)

Well, the guidance below doesn't explicitly say that modules need to be submitted 90 days apart. However, it does say that:

a) FDA wants to allow enough time to review each module, and,
b) FDA expects to issue a decision on each module within 90 days.

Basically, the modular PMA program is designed to allow a staggered (or modular) submission. FDA's stance is that if you are able to submit your modules with less than 90 days between each module, then you would probably opt for a traditional PMA submission. Taken together, it makes sense why your reviewer told you that you need 90 days between each module submission. FDA wants to be able to close out a module before moving on to reviewing the next module.

FDA does note that the manufacturing module can be submitted concurrently with any other module. So if one of your two modules that you'd like to submit 60 days apart is manufacturing, then you are good to go.

https://www.fda.gov/media/73513/download

---------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA

Original Message:
Sent: 26-Oct-2021
From: Anonymous Member
Subject: Time between 2 PMA modules (90 days?)

This message was posted by a user wishing to remain anonymous

Our FDA reviewer said we need to have minimum of 90 days between 2 PMA modules. However, we would like to submit 2 modules in 60 days.
Is there any FDA regulation or guidance which mandates manufacturer's to submit 2 modules with a minimum of 90 days of interval?

Would appreciate input from the community.

Keep in mind that the regulations do not explicitly address modular PMAs at all. Thus, FDA pretty much gets to decide everything as to how they will be approached - and current thinking is usually in their guidance (more of less).

I'd note that other than the manufacturing section, the modules tend to tie up similar FDA staff, so they like to space them up to better manage workload - if you dump in too many you are taking a risk that they ask a bunch of questions just to reset the clock on one or the other. Also note that FDA has to approve your "shell" and proposed submission structure in order to allow you to use the modular process, so if during that process they say you can't submit 2 at a time, you basically can't.

Ginger

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 26-Oct-2021 02:31
From: Anonymous Member
Subject: Time between 2 PMA modules (90 days?)

This message was posted by a user wishing to remain anonymous

Our FDA reviewer said we need to have minimum of 90 days between 2 PMA modules. However, we would like to submit 2 modules in 60 days.
Is there any FDA regulation or guidance which mandates manufacturer's to submit 2 modules with a minimum of 90 days of interval?

Would appreciate input from the community.