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The likelihood of approval by the FDA for a Class II Medical Device
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The likelihood of approval by the FDA for a Class II Medical Device
The likelihood of approval by the FDA for a Class II Medical Device
The likelihood of approval by the FDA for a Class II Medical Device
The likelihood of approval by the FDA for a Class II Medical Device
The likelihood of approval by the FDA for a Class II Medical Device
The likelihood of approval by the FDA for a Class II Medical Device
The likelihood of approval by the FDA for a Class II Medical Device
The likelihood of approval by the FDA for a Class II Medical Device
The likelihood of approval by the FDA for a Class II Medical Device
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The likelihood of approval by the FDA for a Class II Medical Device


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class ii medical device, fda (food and drug administration), medical device registration
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  Post Number #1  
Old 26th July 2017, 10:57 AM
invitro_spain's Avatar
invitro_spain

 
 
Total Posts: 47
Question The likelihood of approval by the FDA for a Class II Medical Device

Hi Folks,

Is there any way to calculate the likelihood of approval by the FDA for a medical device class II?

Do you have any advice?

Thank you in advance

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  Post Number #2  
Old 26th July 2017, 11:18 AM
yodon

 
 
Total Posts: 955
Re: Likelihood of approval by the FDA in medical device

I saw a statistic once that something like close to 70% of submissions were rejected right out of the gate (received the dreaded RTA - Refuse to Accept). (And of course that doesn't take into account those that are rejected after the review process begins). I don't know if that's true or still the case, but it should give you an idea that it's not a cake walk by any means.

Having a seasoned regulatory consultant can help. Having a seasoned regulatory consultant that specializes in the type of device (i.e., has successfully gotten similar devices through the process) is even better.
Thank You to yodon for your informative Post and/or Attachment!
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  Post Number #3  
Old 26th July 2017, 01:19 PM
Edward Reesor

 
 
Total Posts: 35
Re: Likelihood of approval by the FDA in medical device

I was at a conference a few years ago and a winner of an innovative medical device was doing a Q&A about his product. At the time, his company felt that the FDA process was too prohibitive despite the calculated success of his product, therefore he was avoiding the US market altogether.

Mind you, I have heard from North American manufacturers stating that the EU process (especially now with the new reg's) is just as arduous and they are avoiding or pulling out of the European market in favour of North America.

A suggested solution is to hire a consultant (as stated above) or partner with a North American manufacturer who may have an easier process in place.
Thank You to Edward Reesor for your informative Post and/or Attachment!
  Post Number #4  
Old 26th July 2017, 02:45 PM
JeantheBigone

 
 
Total Posts: 128
Re: The likelihood of approval by the FDA for a Class II Medical Device

I'm not aware of any way to calculate a probability of success (FDA does not "approve" Class II or Class I devices through the 510(k) process, they "clear" them, which means that they accept your evidence that your device is substantially equivalent in safety and effectiveness to a legally marketed device).

I do know however how to increase the odds in your favor.

1) Do your homework. Find out exactly what FDA expects by reading guidance documents if any, look at summaries of recently cleared devices to see what others have done

2) Provide an RTA checklist in your submission showing the reviewer exactly where to find each and every item. This speeds up the RTA process and shows the reviewer that you are serious about clearance

This minimizes the chance of not passing the RTA hurdle and reduces the likelihood of "Additional Information" requests, which - if they take longer than 180 days to respond to - will end the review.

Yes the 70 % number of RTA rejections was correct, the process has been improved since then. There were some "humdingers" like not stating the level of concern for software for a submission for latex gloves / explicitly stating that latex gloves do not rely on software so that point can be safely ignored.
Thank You to JeantheBigone for your informative Post and/or Attachment!
  Post Number #5  
Old 26th July 2017, 03:25 PM
Edward Reesor

 
 
Total Posts: 35
Re: The likelihood of approval by the FDA for a Class II Medical Device

Another key factor: as of January 17, 2017, the FDA changed their policy for "Combination Products" and will require a more rigorous clinical evaluation process. To summarize, if your product is a combination of a predicate device "A" and predicate device "B" (e.g. a stent coated with a drug), you cannot say that it is equivalent based on those two distinct products. Unless there is a predicate device that already has the two components already combined, you have to start from scratch.
Thank You to Edward Reesor for your informative Post and/or Attachment!
  Post Number #6  
Old 27th July 2017, 05:57 AM
invitro_spain's Avatar
invitro_spain

 
 
Total Posts: 47
Re: The likelihood of approval by the FDA for a Class II Medical Device

Thank you JeantheBigone for clarifying the concepts "approval" and "clearance". The product is class II and we need to submit a 510(k) as you said. I notice that I misused the terms.
  Post Number #7  
Old 12th August 2017, 05:16 PM
robert.beck

 
 
Total Posts: 39
Re: Likelihood of approval by the FDA in medical device

1. I would like to not believe that statistic, because RTA is easy. it does require attention to detail, but FDA makes it easy if you are awake to get through RTA.

I have yet to have a problem with RTA; I know of one person who failed it but he has dyslexia.

RTA just means that you included the various items, such as a biocompatibility report. it doesn't mean that the included items are any good. for instance, if biocompatibility is supposed to test the patient contact surface and upon reading the report it is clear that device component was not tested, you will not get clearance.

2. Business people generally do not approve of any kind of regulation. I hear this kind of statement often; it means that the company has not figured out how to be successful in the medical device industry and it needs someone to blame. the FDA is a convenient target. recent example: upon failing to log in to an FDA database due to using an incorrect password, the response was "@#!%# FDA" followed by going home early in frustration. Business will take the easiest path; for a given product, if the MDD is easier than QSR it will be Europe. If QSR is easier than MDD, it will be USA.

Last edited by robert.beck; 12th August 2017 at 05:22 PM.
Thank You to robert.beck for your informative Post and/or Attachment!
  Post Number #8  
Old 13th August 2017, 08:48 AM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 6,064
Re: The likelihood of approval by the FDA for a Class II Medical Device

Some additional info:

FDA's Role in Ensuring American Patients Have Access to Safe and Effective Medical Device Technology

Another measure of the performance of the medical device program is that FDA is working with industry to ensure that submissions are complete and ready for review. As a result, the percentage of submissions that are cleared and approved has increased since 2010:

◦The percentage of 510(k)s cleared increased from 73 percent in FY 2010 to 84 percent in FY 2014.

◦The percentage of PMAs approved increased from 59 percent in FY 2010 to 86 percent in FY 2014.
Thanks to Ajit Basrur for your informative Post and/or Attachment!
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