Protocol Agreement - PMA application for Class III Medical devices

C

CBAL08

#1
Dear all,

I wanted to understand the process for PMA application for Medical device(s) (Class III) and wanted to know where does Protocol Agreement fit in the stages of IDE, Clinical investigation , HDE and PMA and so on? FDA being a new thing for me I am just too confused reading all the detailed FDA regulations and guidelines. I am getting more confused than ever.....as I read more.....Please help me find solution.
Any place where i can read in simple words the processes involved with FDA approvals....(presentations, articels related to this issue)

Thank you in advance.

CBAL08
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
Re: Protocol agreement

Thanks for the 'Bump' Coury - Anyone? We have a lot of medical device people here. Please do help out if you can.
 
C

CBAL08

#4
Makes me disheartened that although this thread has so many experts I have failed to get reply from one of them regarding the issues with FDA registration.
Well Thank you for reminding the users here.

Hope and wish to get some feedback from someone soon.

CBAL08:nope:
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#5
Makes me disheartened that although this thread has so many experts I have failed to get reply from one of them regarding the issues with FDA registration.
Well Thank you for reminding the users here.

Hope and wish to get some feedback from someone soon.

CBAL08:nope:

Sometimes response are slow. That is why we, the Moderators "bump" a thread to get back on the visible Posts.

There are reasons that some posts don't get responses. Here are a couple of reasons:

1. The post is not specific enough.

2. It lacks information.

3. Maybe someone is doing research on the issue.

4. The "experts" that would be the most valuable have not been in the Cove for awhile.

5. Thread Title

6. Forum posted in

7. Thread posted on a Friday in the USA

These are just some of reasons that posts do not get either quick responses, or none at all.

Just be patient, because someone with the knowledge will respond.
 
C

CBAL08

#6
Sometimes response are slow. That is why we, the Moderators "bump" a thread to get back on the visible Posts.

There are reasons that some posts don't get responses. Here are a couple of reasons:

1. The post is not specific enough.

2. It lacks information.

3. Maybe someone is doing research on the issue.

4. The "experts" that would be the most valuable have not been in the Cove for awhile.

5. Thread Title

6. Forum posted in

7. Thread posted on a Friday in the USA

These are just some of reasons that posts do not get either quick responses, or none at all.

Just be patient, because someone with the knowledge will respond.
Thank you so much for the reasons behind me not getting the responses from others. I did not want to be specific as
I am in the learning stage. I just wanted to know the flow diagram of the processes that is involved with the registration with FDA ( Class III) devices.
I have been reading the FDA guidelines but getting confused at many terms such as Pre IDE meeting, Pre IDE application, IDE application, Protocol agreement, PMA, Investigation and all sorts of thing.
When I try finding the powerpoint slides i get in one particular topic but not related to the entire process. That is why I wanted some help.

Thank you once again for clearing it for me.
 
M

MIREGMGR

#7
I don't know how one would describe either a simple or a standard flowpath for a Class III device. Getting a Class III device approved is a big project.

If you're totally new to Class IIIs, my guess is that you are going to want to use a consultant your first time through. The device-approval process itself will be expensive enough that the additional cost of a consultant will be minor compared to the potential for additional costs and delays due to suboptimal process management and implementation.
 
C

CBAL08

#8
I don't know how one would describe either a simple or a standard flowpath for a Class III device. Getting a Class III device approved is a big project.

If you're totally new to Class IIIs, my guess is that you are going to want to use a consultant your first time through. The device-approval process itself will be expensive enough that the additional cost of a consultant will be minor compared to the potential for additional costs and delays due to suboptimal process management and implementation.
Thank you for the suggestion. As for hiring a consultant or getting training is for the later stage. I did realize that the whole approval process is a long and an expensive one.
Right now I wanted to know if there was a pathway for that or just the simple flow chart (outline ) to show what follows what....in the entire approval process.

Thank you once again for your comments.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#9
If anyone has a 'generic' flow they can share, or a reference to one such as at another web site, it will be appreciated.

CBAL08 - There are a lot of people who visit hre but of them a small number actually post and help people. As an open forum it's impossible for every question to be answered as fully as one would like, as I'm sure you understand.
 
M

MIREGMGR

#10
I don't know of anything better from the FDA than Premarket Approval Application Modular Review. See pages 11 and 12 for a very bare-bones outline of some of the major steps.

This procedure only applies to those PMAs with relatively long pendency times and complex development work contemporaneous with the application process. If the timeline was more condensed, one would instead file an integrated PMA containing all of the module information.


The FDA's fees are based on their estimates of average staff time allocated to particular examination processes. Note that a PMA fee is approximately 100x that for a 510(k), if the PMA does not require any supplemental filings, which I understand is rare.
 
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