510 k submission RTA (Acceptance Checklist )

[vardag]

Hi all,

We have submitted 510k Traditional Application for our client's medical device.
Now FDA has send 510(k) Acceptance Checklist (RTA) and asked us to submit additional data and tests. After we comply comprehensive review will take place.
My question is whether we should add the information required by FDA Reviewer to the initial 510k application and send it back or attach Addendum to the RTA questionnaire.

Best Regards,

Kamran

 

[Watchcat]

My goal with submissions is to make it quick and easy for FDA to find everything it is looking for. The more they have to dig, the longer their review will take...and the more likely they are to stumble across something new to ask about.

I think this goal is achievable with either approach, and I think FDA would accept either one, but I also think it would be easier for most people to accomplish this goal with the latter approach. I would include a checklist or table that lists every item you are submitting and directly links each item to the specific deficiency it is intended to address, usually by referencing the number of the deficiency, as they are usually numbered somehow.

 

[Ajit Basrur]

Hi all,

We have submitted 510k Traditional Application for our client's medical device.
Now FDA has send 510(k) Acceptance Checklist (RTA) and asked us to submit additional data and tests. After we comply comprehensive review will take place.
My question is whether we should add the information required by FDA Reviewer to the initial 510k application and send it back or attach Addendum to the RTA questionnaire.

Best Regards,

Kamran

Trying to understand your question - are you asking if you need to send the entire Traditional 510(k) package again or just send the revised pages and attach to the RTA?

 

[vardag]

Trying to understand your question - are you asking if you need to send the entire Traditional 510(k) package again or just send the revised pages and attach to the RTA?

Yes Ajit that is the question

 

[vardag]

Yes Ajit that is the question

Meaning should we make changes in the 510k application where required and send the entire package back or just send an Addendum with the answers to the questions raised in RTA.

 

[Ajit Basrur]

Meaning should we make changes in the 510k application where required and send the entire package back or just send an Addendum with the answers to the questions raised in RTA.

An addendum would suffice

 

[Weeder]

An addendum would suffice

Hello,

I have a question about submitting a 510k for an existing device. FDA has great guidance both general and specific to software devices but not everything is clear. My question is for a class II non-invasive device.

If you make changes to your existing device and it involves labeling changes, design changes, etc. but after your risk analysis you find that the safety and effectiveness of the device is not changed and the intended purpose is not changed, is that sufficient justification to not submit a 510k and just document the changes?

The guidance on the one hand says that such changes likely require a submission but on the other hand says that if the safety and effectiveness of the product is not changed than a submission is not required.

What is your opinion about this?

 

[Watchcat]

What is your opinion about this?

My opinion is that it can be risky, in part due to ignorance and in part due to denial.

Many in the medical device industry do not understand how to evaluate the impact of these types of changes on safety and effectiveness. Companies developing software devices...heh. I'm not clear how many FDA inspectors understand how to evaluate this, either. These are clinical questions, and often everyone involved are experts in technology, not clinical. In addition, no one wants to do a 510(k), and denial is definitely not just a river in Egypt. It is also easier to kid yourself about something that you don't fully understand.

If you are confident your evaluation is solid, then it's just a matter of your risk tolerance, keeping in mind that you might get snagged in an inspection, regardless.

 

[Ed Panek]

I second what Watchcat says. It's important to note that we perform a check on each change to the device or labeling, however, a cumulation of smaller changes may also require a new 510(k). FDA published guidance on this in
“Deciding When to Submit a 510(k) for a Change to an Existing Device”, issued on 10/25/2017.
“Deciding When to Submit a 510(k) for a Software Change to an Existing Device”, issued on 10/25/2017.