CytoSorbents Corporation (CTSO)

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EAP: the new FDA super weapon

EAP seems a new acronym that will be famous to all medical device industries that are exporting or selling in the US market. This stands for Expedited Access Program which will be the new weapon for accelerating the authorization to market some high-risk products.

What I want to highlight in this post was the gentle fight between Europe and US to put life-saving products as quick as possible on the market. Few years ago, European industries were fighting against an EU Parliament proposal to introduce high risk medical device product on the market in another way: “Scrutiny procedure”. This is still on the draft and is still today under discussion.

A BCG report from 2012 was showing the difference between the 2 markets regarding the regulatory aspect. As a conclusion it was said that FDA approval occurs 43 months later than EU for the same kind of products. This was a key argument for Europe medical device industry to reject the scrutiny procedure. EAP seems to be the answer to this argument.


FDA vs EU regulatory approval
Your device is eligible to PMA or de novo application. It’s intended to treat or diagnose life-threatening diseases or conditions. And it meets one of the 4 below criterias. Then it can be selected for the EAP.

4 criteria:

NO APPROPRIATE ALTERNATIVE TREATMENT OR MEANS OF DIAGNOSIS EXISTS.

THE DEVICE REPRESENTS A BREAKTHROUGH TECHNOLOGY THAT PROVIDES A CLINICALLY MEANINGFUL ADVANTAGE OVER EXISTING LEGALLY MARKETED TECHNOLOGY.

THE DEVICE OFFERS SIGNIFICANT, CLINICALLY MEANINGFUL ADVANTAGES OVER EXISTING LEGALLY MARKETED ALTERNATIVES.

THE AVAILABILITY OF THE DEVICE IS IN THE BEST INTEREST OF PATIENTS.

Looking at the website, FDA should provide an answer regarding the approval to participate to EAP within 30 days. What is not clearly mentioned is the average timing to get through this process and have the product on the market. When you review the BCG report, you can see that the main reason for FDA delay for approval of high-risk products is not the time needed to review but the time that the dossier is waiting before the review. So if within 30 days we know that our product is accepted to enter the program then I suppose the review will start immediately.

We will follow this new super weapon and see if this can really support FDA or if this is only a new additional administrative layer added to the current structure.