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:
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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.*
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.
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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.
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2. Change: The manufacturer of an IVD updates their labeling by changing the device from prescription use only to over-the-counter use.*
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).*