The Regulatory Approval Process Explained

Tracey Kruger

Tracey Kruger

Cedric Navarro

Cedric Navarro


Howard Samuels: Would you describe the process for regulatory approval for new cochlear implant hardware and software?

Cedric Navarro:  In the United States, the regulatory approval process for new cochlear implant hardware whether it is the implant itself, the externals, or the software, is the same.  The manufacturer submits a 180-day PMA (Pre-Market Approval) supplement to support the change. Additional information that may be required is a clinical trial.  When we make a significant change, or introduce a new feature or new hardware, we must gain approval from FDA via a PMA Supplement.

What that means is from the day you submit, the FDA has 180 days to review all of the data, to assess your claims, and determine whether you have provided enough data to show that there are no safety issues or any efficacy issues.

For example, ClearVoice is a groundbreaking algorithm that our patients just love, and that there has been a lot of positive feedback about.  ClearVoice is actually the first sound-processing algorithm in the industry that has ever been given a superiority claim by the FDA.  Prior to that, all of the sound-processing strategies in the industry had to prove that the new sound-processing strategy was no worse on average than what patients had before.  And that’s a pretty easy bar to hit.

Whereas for ClearVoice, we believed strongly that this technology would improve patient performance and clinically, statistically speaking, would demonstrate that it is superior.  In order for us to make the new claim, we had to conduct a clinical trial.    If you have a new claim, you have to do a clinical trial before you do your 180-day supplement.

HS:  If Advanced Bionics had chosen to introduce ClearVoice as an algorithm, and not say that it is superior, but that it is an algorithm intended for noise reduction, then you would just submit for the 180-day process without having to conduct the study, correct?

CN:  Well the speech enhancement algorithm itself is a new feature.  So ClearVoice is a new feature that we didn’t have before.  We would have had to do a clinical trial, but it would have been simpler, because it would have been a non-inferiority design with no claim of improved performance benefit.

HS:  So this is something that you choose in your submission to the FDA?  You say ‘we want to demonstrate that this is superior; here is our data; and we have conducted the clinical trial.  Now start your 180-day clock.’

About the 180-day clock, is that the target time frame?

CN:  The FDA is not held to that.  Because of various issues, very rarely do you get a submission approved more quickly than 180 days.  At Advanced Bionics, our relationship with the agency is really great, so on some external devices, we have beaten the 180-day clock.  But if you look at FDA’s performance objectives, and they publish these, the 180 days is not what the performance goal is.  The goal, for what is called a 180-day supplement, is to have 80% of the supplements reviewed and approved by 230 days.

HS:  To summarize, if you don’t have a superiority claim, then you can just make a submission.  If you have a superiority claim, you run clinical trials, and then make a submission.  Then there is this nominal 180-day period; the FDA studies it, thinks about it, takes people out to dinner, I don’t know what they do.

CN:  No, they don’t do that! (laughter)

HS:  Then you get a phone call one day, or a fax, and it says …

CN:  We will get a letter from the FDA that will say ‘Your approval has been granted.’  And there are conditions of approval, that talk about any follow-up reports or any other information that you need to provide.

HS:  But sometimes it is not approved.  What happens then?

CN:  In the review cycle, if they find a deficiency, or if they don’t have enough information in order to grant an approval, they will send you an additional information request.  All of this is in written format.  You will get a letter stating the additional data that you need to provide.  Or maybe they just have some questions they would like to have answered.

The 180 days is their review time.  That doesn’t mean it goes from January 1st to July 1st.  When they write up questions, it actually stops the review cycle.  So if they go through 100 days, and at the end of 100 days they send you five questions, then the clock stops at that 100 days.  And then what happens is they restart the clock when the manufacturer responds.

Next: The Logistics of Introducing a New Product.