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

[robertjbeck]

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?

 

[mihzago]

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.

 

[robertjbeck]

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 ...

 

[Marc]

We appreciate your keeping us informed.

 

[mihzago]

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.

 

[Mark Meer]

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.

 

[MnMedDev]

That is frustrating - and actually inconsistent with what FDA guidance suggests - even final guidance issued just the other week!

#1 FDA's 510(k) guidance (c2014) suggests that Rx-OTC is merely a difference in indications, not intended use:

- Page 24 -
1. New or Modified Indications for Use – Same Intended Use*
In rare instances, FDA may rely upon clinical data to determine that new or modified indications for use fall within the same intended use as a predicate device.*
Illustrative Examples:*
The new device is an IVD that is indicated for over-the-counter use, whereas the predicate device is indicated for prescription use in the home or prescription use in a clinical setting. The newly indicated test population might fall within the intended use of the predicate device. Clinical data (demonstrating that the user can collect the sample, generate an accurate result, and adequately interpret the result) might establish that the indication for use for the new device falls within the intended use of the predicate device.*

#2 FDA's 510(k) modifications guidance (c2017) suggests it Rx-OTC could significantly affect S or E but again says it's a change in indications, not intended use. It also says it perhaps changes the "scope" of intended users, but that is not the same as intended use.

- Page 17 -
A.1.2 Is it a change from prescription (Rx) to over the counter (OTC) use?*
FDA has found that the directions for use necessary for health care professionals to use a device safely and effectively can be significantly different from the directions for use necessary for lay users to use that same device safely and effectively. Therefore, changing a device labeled for prescription use only to a device that is labeled for OTC use typically could significantly affect the safety or effectiveness and would likely require submission of a new 510(k). Changing a device labeled for OTC use to prescription use, however, would likely not require submission of a new 510(k) because it is unlikely that the associated labeling changes could significantly affect the safety or effectiveness of the device.

- Page 44 -
2. Change: The manufacturer of an IVD updates their labeling by changing the device from prescription use only to over-the-counter use.*
Relevant questions:*
A1– Is it a change in the indications for use statement? Yes. The revised labeling is a change in the indications for use statement of the device. Proceed to A1.1 -A1.5.*
A1.2 – Is it a change from prescription to over the counter (OTC) use? Yes. The revised labeling expands the scope of intended users of the device to lay users, which could significantly affect the safety or effectiveness of the device.*
Decision: New 510(k).*