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OTC with Rx Predicate - 510(k) for a Class II medical device
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OTC with Rx Predicate - 510(k) for a Class II medical device
OTC with Rx Predicate - 510(k) for a Class II medical device
OTC with Rx Predicate - 510(k) for a Class II medical device
OTC with Rx Predicate - 510(k) for a Class II medical device
OTC with Rx Predicate - 510(k) for a Class II medical device
OTC with Rx Predicate - 510(k) for a Class II medical device
OTC with Rx Predicate - 510(k) for a Class II medical device
OTC with Rx Predicate - 510(k) for a Class II medical device
OTC with Rx Predicate - 510(k) for a Class II medical device
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OTC with Rx Predicate - 510(k) for a Class II medical device


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Some Related Topic Tags
class ii medical device, otc (over the counter) medical devices, predicate devices and parts, 510(k)
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  Post Number #1  
Old 14th May 2016, 11:19 AM
robertjbeck

 
 
Total Posts: 39
Please Help! OTC with Rx Predicate - 510(k) for a Class II medical device

I am planning a 510(k) for a class II medical device. unfortunately all of the likely predicates are Rx devices, and this new device will be OTC. FDA has responded with a statement that risks associated with having the device available to the general public must be considered and mitigated. This makes sense but is too general.

I have looked at the Rx-To-OTC Switch program for drugs, deNovo applications, and will probably take the pre-submission route.

so my questions are:

1) does anyone have any experience with submitting a 510(k) for an OTC device, especially where the predicate is not OTC?
2) is the lack of an OTC predicate a deal-breaker, or can it be dealt with by providing adequate human factors data?

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  Post Number #2  
Old 16th May 2016, 01:16 PM
mihzago

 
 
Total Posts: 148
Re: OTC with Rx Predicate - 510(k) for a Class II medical device

Having an OTC predicate is not a requirement, but I'll have to provide clinical and/or usability data showing that the users can use the device properly without professional oversight e.g. ability to select the right product (size, shape, type, etc), properly apply or use it, understand the data or results provided, and take appropriate action.

One example I have handy is K140186.
Thank You to mihzago for your informative Post and/or Attachment!
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  Post Number #3  
Old 11th October 2017, 10:16 PM
robertjbeck

 
 
Total Posts: 39
Re: OTC with Rx Predicate - 510(k) for a Class II medical device

Well, I finally did send in a 510(k) with an Rx predicate. human factors study, risk assessment, MAUDE database search, predicate comparison, etc. The 510(k) was soundly rejected on the basis that Rx and OTC are different intended uses, therefore the predicate is invalid, therefore the 510(k) route is not the correct route. The reviewer suggested deNovo. working on a response ...
Thank You to robertjbeck for your informative Post and/or Attachment!
  Post Number #4  
Old 12th October 2017, 02:44 AM
Marc's Avatar
Marc

 
 
Total Posts: 26,030
Re: OTC with Rx Predicate - 510(k) for a Class II medical device

We appreciate your keeping us informed.
  Post Number #5  
Old 12th October 2017, 08:49 AM
mihzago

 
 
Total Posts: 148
Re: OTC with Rx Predicate - 510(k) for a Class II medical device

it appears that the FDA views the intended use in an ever stricter manner.

DuVal Law (DuVal & Associates, PA | Drug, Device, and Food Lawyers) has some interesting articles about that (search under Client Alerts Client Alerts | DuVal & Associates, PA | Drug, Device, and Food Lawyers).

If your company has some money, they could probably also help you pushing this through.
Thanks to mihzago for your informative Post and/or Attachment!
  Post Number #6  
Old 12th October 2017, 07:31 PM
Mark Meer

 
 
Total Posts: 667
Re: OTC with Rx Predicate - 510(k) for a Class II medical device

Quote:
In Reply to Parent Post by robertjbeck View Post

Well, I finally did send in a 510(k) with an Rx predicate. human factors study, risk assessment, MAUDE database search, predicate comparison, etc. The 510(k) was soundly rejected on the basis that Rx and OTC are different intended uses, therefore the predicate is invalid, therefore the 510(k) route is not the correct route. The reviewer suggested deNovo. working on a response ...
This is unfortunate.

I wonder if it might help to just submit the 510(k) with the predicate's Rx, and once that goes through, then apply to ammend the intended use afterwards to OTC.

Otherwise, do keep us up to date on the deNovo route. There are many Rx devices that now - through technological and design innovations - can be safely sold OTC...so I suspect there are a lot of people with the same question.
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