Preparing for Investigational Device Exemption

[dinakim_zv]

Hi everyone,

I i hope i am asking the right question and someone can help

I'm working for a small class 3 medical device company (outside the US) and we are preparing for IDE. (currently we are initiating a performance testing in one of the US hospitals).

I am gathering knowledge around IDE application process & required actions and documents from the manufacturer.
As I realised, IDE exempts the manufacturer from full on Quality Regulation System (21 CFR820), but Design control (21 CFR 820.30), Labeling and Packaging Control (21CFR820.120-130) and Handling, Storage, Distribution, and Installation (21 CFR 820.140-170) is still required.

Am I right about this?

Also, DHF, DHR and DMR are needed for IDE, right?

p.s. my previous question was deleted accidentally as for some reason there was a font issue and the website thought it was a spam.

Thank you in advance, be safe

 

[shimonv]

The governing CFR for IDE is 21 part 812. FDA has guidance document for IDE applications. You should study them carefully.

Formally, you are exempt from good manufacturing practices except for 820.30. Part 812 is like your "GMP for IDE" requirements; it describes the minimum requirements you should have. For example, section 812.5 describes the "Labeling of investigational devices"; you should follow that and not the corresponding section in QSR 820.120-130 which references UDI which is not applicable for IDE devices.

Shimon

 

[dinakim_zv]

Thank you Shimon

Okay so instead of referring to 820, one should be only referring to 812. This I got now, thank you

In 812, one should provide "4. Manufacturing information (methods, facilities, controls for manufact., storaging, packaging, installation of the device)". Is this not a a DMR in essense?

Thank you and sorry if i did not understand smth.
Have a good day

Dina

 

[shimonv]

They require a description of what you have in terms of manufacturing capability to determine that it is sufficient to build devices for human trial.
As you know, the DMR is only ready after design transfer activities are completed.
I guess you could call this "sneak peek" DMR

 

[dinakim_zv]

Shimov, thank you very much!

 

[monoj mon]

In the IDE application, for the the manufacturing capability description (as Shimon has said), the information can be categorized into the following points; or you can add/remove points if deemed necessary/unnecessary.

1. Manufacturing Overview
2. Manufacturing Flowchart
3. Manufacturing Method Description
4. Manufacturing Facility Description
5. Design Control Overview
6. Process Controls

 

[dinakim_zv]

In the IDE application, for the the manufacturing capability description (as Shimon has said), the information can be categorized into the following points; or you can add/remove points if deemed necessary/unnecessary.

1. Manufacturing Overview
2. Manufacturing Flowchart
3. Manufacturing Method Description
4. Manufacturing Facility Description
5. Design Control Overview
6. Process Controls

Hi monoj mon,

thank you for your reply.

Can you tell me more about the 5th and 6th points? In what format does it USUALLY come? I always thought that the design control overview if basically the DHF?

 

[monoj mon]

Hi monoj mon,

thank you for your reply.

Can you tell me more about the 5th and 6th points? In what format does it USUALLY come? I always thought that the design control overview if basically the DHF?

In our case we write summaries explaining phases/steps, roles and responsibilities including drawings where necessary. It covers merely few pages depending on how complex your device is. You may refer to your document number, but I think providing a DHF is not necessary.

 

[dinakim_zv]

I see, so it looks like the volume of the documentation submitted for the IDE is incomparable to that of premarket submission...?
Also, I have not seen any requirements about the EMC and safety reports?? I assume logically that one should provide that, no???

Thank you for your inputs!

In our case we write summaries explaining phases/steps, roles and responsibilities including drawings where necessary. It covers merely few pages depending on how complex your device is. You may refer to your document number, but I think providing a DHF is not necessary.

 

[monoj mon]

I see, so it looks like the volume of the documentation submitted for the IDE is incomparable to that of premarket submission...?
Also, I have not seen any requirements about the EMC and safety reports?? I assume logically that one should provide that, no???

Thank you for your inputs!

I think you already have checked this checklist from FDA, content are to some extent similar to the pre-market notifications. Except, with IDE submission you will need a complete Investigational Plan. I am not sure about the EMC and Safety reports together with the IDE, but if you are dealing with an Electrical or Electronic device then it shall be conducted prior to IDE submission! right!